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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81039

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

Open FDA event record

Event summary

Timeline bucket
January 12, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Beckman Coulter Inc.

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

2 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 2

1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics

Z-0471-2019
Recall number
Z-0471-2019
Initiated
January 12, 2018
Classification
Class I
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
3115

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

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

A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

Code information

FC 500 Catalog Num FC 500" Flow Cytometer MCL with UPS 626553 FC 500" Flow Cytometer MPL 626554 FC 500" MCL Flow Cytometer 5 Color (100V) 6605627 FC 500" MCL Flow Cytometer 5 Color (120V) 6605628 FC 500" MCL Flow Cytometer 5 Color (220V) 6605629 FC 500" MCL Flow Cytometer 5 Color (240V) 6605630 FC 500 Flow Cytometer, Remfg Assy, 5 Clr (220V) A89264 FC 500" Flow Cytometer 100-240V, 50-60HZ, Remfg Assy A89151 FC 500 Recond MCL UPS Flow Cytometer 100-240V, 50-60HZ A88262 FC 500 Flow Cytometer 100-240V A88263 All products manufactured affected for the time period: FC-500 From 01/22/2002 to 01/31/2018 EPICS XL/XL-MCL From 11/01/1992 to 03/15/2013

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico. OUS: FC 500: Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, Hungary, Sri Lanka, Uruguay, Canada, New Zealand, Switzerland, Gabon, Portugal, Mexico, Singapore, Monaco, Hong Kong, Guadeloupe, Zambia, United Arab Emirates, Ireland, Reunion, Poland, Egypt, Slovakia, Croatia, Brazil, Chile, Bahrain, Slovenia, Bosnia and Herzegovina, Greece, Myanmar, Morocco, Serbia, Philippines, Lebanon, Romania, Moldova, Qatar, Barbados, Iraq, Oman, Namibia, Indonesia, Thailand, The Bahamas, Macau, El Salvador, Panama, Denmark, Venezuela, Azerbaijan, Israel, Colombia, Peru, Malaysia, Vietnam, Tunisia, Kuwait, Kenya, Libya, Latvia, Russia, Belarus, Ukraine, Kazakhstan, Taiwan EPICS XL: Albania, Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Bulgaria, Burundi, Cameroon, Canada, China, Congo, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Egypt, Ethiopia, France, Germany, Greece, Guinea, Guinea-Bissau, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macau, Malawi, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, The Bahamas, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Zambia, Zimbabwe

device · product 2 of 2

COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software

Z-0472-2019
Recall number
Z-0472-2019
Initiated
January 12, 2018
Classification
Class I
Status
Terminated
Recalling firm
Beckman Coulter Inc.
Quantity
2549

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

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

A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots. This can impact patient results for any application.

Code information

EPICS Catalog Number: EPICS CL 3 COLOR W/MCL 220V 6604985 XL 4CLR FLOW CENTRE 220V AC 6605465 PKG; 4 COLOR XL M/M (220V) 6605465R XL-MCL 4 CLR FLOW CENTRE 220V A 6605437 XL-MCL 4 CLR FLOW CENTRE 240V AC 6605438 XL-MCL 4 CLR FLOW CENTRE 220V A 6605437R EPICS XL 4 COLORS 115V 6604714 XL-MCL 4CLR FLOW CENTRE 100VAC 6605435 TN, XL Flow Cytometer 100-240V, 50/60Hz 626551 EPICS XL 3 COLOR 230V 6604726 EPICS XL 4 CLR/ MCL 115V 6604988 EPICS XL 4 CLR/ MCL 220V 6604989 XL 4CLR FLOW CENTRE 240VAC 6605466 R-EPICS XL 3 COLOR 115V 6604713 XL 4 CLR W/FLOW 1 YR WARR 6605464 PKG;4 COLOR XL M/M (100V) 6605463 EPICS XL 4 COLOR 220V 6604723 TN, XL/MCL Flow Cytometer 100-240V, 50/60Hz 626552 EPICS XL 3 COLOR 240V 6604725 EPICS XL 4 CLR/MCL 240V 6604990 4 CLR,MCL,MM(120V)REFURB 6605436R XL-MCL 4 CLR FLOWCENTRE 240VAC 6605438R 4 COLOR XL M/M (120V)REFURB 6605464R XL 4CLR FLOW CENTRE 240VAC 6605466R 4 CLR, MCL, MM PKG (240V) 6605438U XL-MCL 4 CLR W/FLOW (RECOND) 6605436U All products manufactured affected for the time period: FC-500 From 01/22/2002 to 01/31/2018 EPICS XL/XL-MCL From 11/01/1992 to 03/15/2013

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico. OUS: FC 500: Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, Hungary, Sri Lanka, Uruguay, Canada, New Zealand, Switzerland, Gabon, Portugal, Mexico, Singapore, Monaco, Hong Kong, Guadeloupe, Zambia, United Arab Emirates, Ireland, Reunion, Poland, Egypt, Slovakia, Croatia, Brazil, Chile, Bahrain, Slovenia, Bosnia and Herzegovina, Greece, Myanmar, Morocco, Serbia, Philippines, Lebanon, Romania, Moldova, Qatar, Barbados, Iraq, Oman, Namibia, Indonesia, Thailand, The Bahamas, Macau, El Salvador, Panama, Denmark, Venezuela, Azerbaijan, Israel, Colombia, Peru, Malaysia, Vietnam, Tunisia, Kuwait, Kenya, Libya, Latvia, Russia, Belarus, Ukraine, Kazakhstan, Taiwan EPICS XL: Albania, Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Botswana, Bulgaria, Burundi, Cameroon, Canada, China, Congo, Croatia, Cyprus, Czech Republic, Denmark, Dominican, Republic, Egypt, Ethiopia, France, Germany, Greece, Guinea, Guinea-Bissau, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macau, Malawi, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tanzania, The Bahamas, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Zambia, Zimbabwe