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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95729

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 01, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Becton, Dickinson and Company, BD Bio Sciences

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. " It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

Z-0745-2025
Recall number
Z-0745-2025
Initiated
November 01, 2024
Classification
Class II
Status
Ongoing
Quantity
15 power supplies

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users

Code information

Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 662875 UDI-DI code: 00382906628756 Instrument Serial Numbers/ Power Supply Serial Numbers: Z662875000119 V23300114 Z662875000117 V23300192 Z662875000112 V23300098 Z662875000123 V23300321 Z662875000105 V23090179 Z662875000104 V23090157 Z662875000107 V23090507 Z662875000102 V23090029 Z662875000103 V23090114 Z662875000106 V23090177 Z662875000108 V23180127 Z662875000110 V23300074 Z662875000111 V23090430 Z662875000109 V23300294 Z662875000116 V23300051

Distribution pattern

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.

device · product 2 of 5

Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket

Z-0746-2025
Recall number
Z-0746-2025
Initiated
November 01, 2024
Classification
Class II
Status
Ongoing
Quantity
20 power supplies

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Code information

Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted. Catalog Number: 662876 UDI-DI code: 00382906628763 Instrument Serial Numbers / Power Supply Serial Numbers: Z662876000065 V23300165 Z662876000044 V23090245 Z662876000045 V23090338 Z662876000048 V23180201 Z662876000047 V23180258 Z662876000051 V23180476 Z662876000050 V23180466 Z662876000049 V23180113 Z662876000052 V23180415 Z662876000053 V23180190 Z662876000056 V23300354 Z662876000055 V23300347 Z662876000057 V23300249 Z662876000059 V23300174 Z662876000061 V23300274 Z662876000062 V23300132 Z662876000060 V23300286 Z662876000063 V23300163 Z662876000066 V23300232 Z662876000054 V23300408

Distribution pattern

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.

device · product 3 of 5

FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket

Z-0747-2025
Recall number
Z-0747-2025
Initiated
November 01, 2024
Classification
Class II
Status
Ongoing
Quantity
16 power supplies

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Code information

Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 662877 UDI-DI code: 00382906628770 Instrument Serial Numbers / Power Supply Serial Numbers: Z662877000064 V23180197 Z662877000053 V23090166 Z662877000052 V23090305 Z662877000054 V23090341 Z662877000051 V23090060 Z662877000056 V23090037 Z662877000058 V23090446 Z662877000055 V23090190 Z662877000061 V23180242 Z662877000057 V23090456 Z662877000060 V23180454 Z662877000065 V23180453 Z662877000062 V23300158 Z662877000063 V23300110 Z662877000059 V23180441 Z662877000068 V23300012

Distribution pattern

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.

device · product 4 of 5

FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a computer workstation. System options include an automated FACS Universal Loader and a barcode reader. The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part of four available manufactured instrument configurations. BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser The lower level configurations are upgradeable to higher level configurations by adding filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO). All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in height by 24.93 inches in width by 22.8 inches in depth. The K201814 clearance document describes the device as follows: Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer. The modified BD FACSLyric Flow Cytometer consists of the following components. " FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations) " FACSuite Clinical Software (version 1.4) " Modified FACS Universal Loader: updated shaker and modification to the door lock and sensor connections " Modified CMS firmware BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system consists of all the above components as FACSLyric Flow Cytometer and additionally contain: " BD FACSDuet Sample Preparation system physically and data integrated with the BD FACSLyric Flow Cytometer " FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution. " Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor connections, addition of stabilization bracket

Z-0748-2025
Recall number
Z-0748-2025
Initiated
November 01, 2024
Classification
Class II
Status
Ongoing
Quantity
49 power supplies

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Code information

Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 662878 UDI-DI code: 00382906628787 Instrument Serial Numbers / Power Supply Serial Numbers: Z662878000426 V23180200 Z662878000412 V23180272 Z662878000410 V23180312 Z662878000046 UNK Z662878000319 UNK Z662878000367 V23090032 Z662878000373 V23090334 Z662878000370 V23090030 Z662878000371 V23090076 Z662878000377 V23090329 Z662878000369 V23090021 Z662878000375 V23090010 Z662878000372 V23090176 Z662878000378 V23090048 Z662878000380 V23090136 Z662878000374 V23090354 Z662878000383 V23090365 Z662878000379 V23090361 Z662878000401 V23180013 Z662878000382 V23090191 Z662878000381 V23090196 Z662878000421 V23180001 Z662878000387 V23090396 Z662878000420 V23180150 Z662878000425 V23180449 Z662878000399 V23180007 Z662878000400 V23090381 Z662878000422 V23090460 Z662878000386 V23090409 Z662878000388 V23090374 Z662878000390 V23090408 Z662878000368 V23090036 Z662878000431 V23300473 Z662878000432 V23300472 Z662878000389 V23090387 Z662878000423 V23180014 Z662878000454 V23300221 Z662878000413 V23180117 Z662878000376 V23090122 Z662878000455 V23300323 Z662878000453 V23300273 Z662878000411 V23180096 Z662878000385 V23090172 Z662878000384 V23090499 Z662878000394 V23090394 Z662878000395 V23180408 Z662878000434 V23180118 Z662878000435 V23300149 Z662878000111 UNK

Distribution pattern

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.

device · product 5 of 5

FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181

Z-0749-2025
Recall number
Z-0749-2025
Initiated
November 01, 2024
Classification
Class II
Status
Ongoing
Quantity
139 power supplies

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.

Code information

Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted Catalog Number: 663518 UDI-DI code: 00382906635181 Instrument Serial Numbers / Power Supply Serial Numbers: MP6635180000004 V23180079 MP6635180000008 V23180205 MP6635180000005 V23180222 MP6635180000006 V23180230 Z663518000594 V23180062 Z663518000529 V23300356 Z663518000526 V23300128 Z663518000470 V23180355 Z663518000471 V23180343 Z663518000456 V23090485 Z663518000433 V23090505 Z663518000402 V23090220 Z663518000165 UNK Z663518000196 UNK Z663518000214 UNK Z663518000338 V23090066 Z663518000342 V23090294 Z663518000339 V23090178 Z663518000349 V23090224 Z663518000350 V23090127 Z663518000357 V23090035 Z663518000343 V23090118 Z663518000346 V23090121 Z663518000352 V23090319 Z663518000360 V23090242 Z663518000355 V23090002 Z663518000359 V23090351 Z663518000340 V23090283 Z663518000337 V23090300 Z663518000335 V23090301 Z663518000361 V23090352 Z663518000362 V23090113 Z663518000347 V23090077 Z663518000336 V23090304 Z663518000341 V23090292 Z663518000365 V23090235 Z663518000358 V23090328 Z663518000353 V23090371 Z663518000382 V23090360 Z663518000369 V23090085 Z663518000380 V23090169 Z663518000351 V23090025 Z663518000348 V23090171 Z663518000356 V23090273 Z663518000378 V23090090 Z663518000345 V23090018 Z663518000367 V23090226 Z663518000385 V23090369 Z663518000376 V23090356 Z663518000379 V23090041 Z663518000354 V23090359 Z663518000384 V23090490 Z663518000386 V23090262 Z663518000388 V23090162 Z663518000387 V23090264 Z663518000364 V23090084 Z663518000389 V23090072 Z663518000381 V23090059 Z663518000375 V23090237 Z663518000390 V23090079 Z663518000377 V23090198 Z663518000383 V23090259 Z663518000444 V23180285 Z663518000391 V23090068 Z663518000373 V23090200 Z663518000372 V23090086 Z663518000445 V23090375 Z663518000442 V23180281 Z663518000374 V23090251 Z663518000441 V23180332 Z663518000370 V23090233 Z663518000440 V23180189 Z663518000463 V23180015 Z663518000449 V23090492 Z663518000446 V23180237 Z663518000439 V23180186 Z663518000392 V23090502 Z663518000366 V23090089 Z663518000450 V23090476 Z663518000468 V23180145 Z663518000447 V23180183 Z663518000451 V23090466 Z663518000461 V23090461 Z663518000460 V23180112 Z663518000462 V23180012 Z663518000457 V23090475 Z663518000443 V23180323 Z663518000489 V23180209 Z663518000448 V23090468 Z663518000487 V23180301 Z663518000483 V23300185 Z663518000478 V23180094 Z663518000491 V23300409 Z663518000479 V23180033 Z663518000488 V23180176 Z663518000459 V23090464 Z663518000492 V23180177 Z663518000493 V23300434 Z663518000466 V23180066 Z663518000481 V23300147 Z663518000408 V23090390 Z663518000412 V23090422 Z663518000480 V23180450 Z663518000458 V23090393 Z663518000411 V23090400 Z663518000498 V23180172 Z663518000486 V23180028 Z663518000484 V23180447 Z663518000521 V23300068 Z663518000415 V23090126 Z663518000497 V23180187 Z663518000494 V23180149 Z663518000414 V23090412 Z663518000485 V23180108 Z663518000406 V23090039 Z663518000464 V23180086 Z663518000482 V23180467 Z663518000416 V23090295 Z663518000363 V23090123 Z663518000417 V23090443 Z663518000410 V23090442 Z663518000413 V23090455 Z663518000522 V23300405 Z663518000528 V23300351 Z663518000405 V23090054 Z663518000519 V23300086 Z663518000418 V23090175 Z663518000371 V23090236 Z663518000469 V23180097 Z663518000548 V23300399 Z663518000549 V23180424 Z663518000547 V23300319 Z663518000555 V23300006 Z663518000544 V23300233 Z663518000556 V23300022 Z663518000559 V23300151 Z663518000523 V23300129 Z663518000551 V23180369 Z663518000527 V23300346 Z663518000524 V23300082 Z663518000531 V23300126 Z663518000407 V23090267 Z663518000490 V23300432 Z663518000495 V23180167 Z663518000565 V23300247 Z663518000568 V23300245 Z663518000566 V23300312 Z663518000569 V23300272 Z663518000546 V23180129 Z663518000525 V23300195 Z663518000409 V23090406 Z663518000530 V23300358 Z663518000398 V23090272 Z663518000368 V23090303 Z663518000397 V23090082 Z663518000573 V23300100 Z663518000576 V23300285 Z663518000571 V23300284 Z663518000572 V23300243 Z663518000393 V23090263 Z663518000394 V23090265 Z663518000575 V23300292 Z663518000432 V23090510 Z663518000574 V23300480 Z663518000577 V23300281 Z663518000399 V23090253 Z663518000396 V23090258 Z663518000401 V23090289 Z663518000400 V23090355 Z663518000583 V23300116 Z663518000567 V23300239 Z663518000570 V23300254 Z663518000453 V23090472 Z663518000437 V23090500 Z663518000438 V23090498 Z663518000452 V23090426 Z663518000593 V23300164 Z663518000395 V23090078 Z663518000455 V23180254 Z663518000404 V23090138 Z663518000421 V23090384 Z663518000403 V23090088 Z663518000472 V23180346 Z663518000473 V23180130 Z663518000474 V23180341 Z663518000420 V23090404 Z663518000435 V23090503 Z663518000592 V23180107 Z663518000434 V23090445 Z663518000454 V23180199 Z663518000436 V23090506 Z663518000344 V23090161 Z663518000465 V23180064

Distribution pattern

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.