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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83603

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

Open FDA event record

Event summary

Timeline bucket
August 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton, Dickinson and Company, BD Biosciences

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

9 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 9

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes

Z-0066-2020
Recall number
Z-0066-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: Z662875000001, Z662875000007, Z662875000008, Z662875000009, Z662875000011, Z662875000012, Z662875000013, Z662875000014, Z662875000015, Z662875000016, Z662875000017, Z662875000018.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 2 of 9

BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes

Z-0067-2020
Recall number
Z-0067-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial number: Z662876000007.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 3 of 9

BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes

Z-0068-2020
Recall number
Z-0068-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: Z662877000001, Z662877000002, Z662877000003, Z662877000004, Z662877000005, Z662877000006, Z662877000007, Z662877000008.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 4 of 9

BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes

Z-0069-2020
Recall number
Z-0069-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
78

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: Z662878000003, Z662878000041, Z662878000042, Z662878000043, Z662878000044, Z662878000045, Z662878000046, Z662878000047, Z662878000049, Z662878000050, Z662878000051, Z662878000052, Z662878000053, Z662878000054, Z662878000055, Z662878000056, Z662878000057, Z662878000058, Z662878000059, Z662878000060, Z662878000061, Z662878000062, Z662878000063, Z662878000064, Z662878000065, Z662878000066, Z662878000067, Z662878000068, Z662878000069, Z662878000070, Z662878000071, Z662878000072, Z662878000073, Z662878000074, Z662878000075, Z662878000076, Z662878000077, Z662878000078, Z662878000079, Z662878000080, Z662878000081, Z662878000082, Z662878000083, Z662878000084, Z662878000085, Z662878000086, Z662878000087, Z662878000088, Z662878000089, Z662878000090, Z662878000091, Z662878000092, Z662878000093, Z662878000094, Z662878000095, Z662878000096, Z662878000097, Z662878000098, Z662878000105, Z662878000106, Z662878000107, Z662878000108, Z662878000109, Z662878000110, Z662878000111, Z662878000112, Z662878000113, Z662878000114, Z662878000115, Z662878000116, Z662878000117, Z662878000118, Z662878000119, Z662878000120, Z662878000121, Z662878000122, Z662878000123, Z662878000048.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 5 of 9

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes

Z-0070-2020
Recall number
Z-0070-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: R651164000007, R651164000016, R651164000017, R651164000019, R651164000020, R651164000021, R651164000022, R651164000023, R651164000024, R651164000025, R651164000026, R651164000027, R651164000028, R651164000029, R651164000030, R651164000031, R651164000032, R651164000033, R651164000034, R651164000035, R651164000036.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 6 of 9

BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes

Z-0071-2020
Recall number
Z-0071-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
36

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: R651165000010, R651165000023, R651165000024, R651165000025, R651165000026, R651165000027, R651165000028, R651165000029, R651165000030, R651165000031, R651165000032, R651165000033, R651165000034, R651165000035, R651165000036, R651165000037, R651165000038, R651165000039, R651165000040, R651165000041, R651165000042, R651165000043, R651165000044, R651165000045, R651165000046, R651165000048, R651165000049, R651165000050, R651165000051, R651165000052, R651165000053, R651165000054, R651165000055, R651165000057, R651165000058, R651165000060.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 7 of 9

BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes

Z-0072-2020
Recall number
Z-0072-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: R654587000008, R654587000009, R654587000010, R654587000011, R654587000024, R654587000026, R654587000027, R654587000028, R654587000029, R654587000030, R654587000031, R654587000032, R654587000033, R654587000034, R654587000035, R654587000036, R654587000037, R654587000038, R654587000039, R654587000040, R654587000041, R654587000042, R654587000043, R654587000044, R654587000045, R654587000046, R654587000047, R654587000048, R65458700020, Z654587P027.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 8 of 9

BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes

Z-0073-2020
Recall number
Z-0073-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
236

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: 9180000057, 9180000219, 9180000283, 0000001R6591800, R658180000282, R6591800000082, R6591800000083, R659180000045, R659180000051, R659180000061, R659180000063, R659180000064, R659180000068, R659180000071, R659180000075, R659180000089, R659180000099, R659180000137, R659180000167, R659180000196, R659180000202, R659180000204, R659180000211, R659180000213, R659180000229, R659180000230, R659180000231, R659180000232, R659180000233, R659180000234, R659180000235, R659180000236, R659180000237, R659180000239, R659180000240, R659180000241, R659180000242, R659180000243, R659180000244, R659180000245, R659180000246, R659180000247, R659180000248, R659180000249, R659180000250, R659180000251, R659180000252, R659180000253, R659180000254, R659180000255, R659180000256, R659180000257, R659180000258, R659180000259, R659180000260, R659180000261, R659180000262, R659180000263, R659180000264, R659180000265, R659180000266, R659180000267, R659180000268, R659180000269, R659180000270, R659180000272, R659180000273, R659180000274, R659180000275, R659180000276, R659180000277, R659180000278, R659180000279, R659180000280, R659180000281, R659180000282, R659180000283, R659180000284, R659180000285, R659180000286, R659180000287, R659180000288, R659180000289, R659180000290, R659180000291, R659180000292, R659180000293, R659180000294, R659180000295, R659180000296, R659180000297, R659180000298, R659180000299, R659180000300, R659180000301, R659180000302, R659180000303, R659180000304, R659180000305, R659180000306, R659180000307, R659180000311, R659180000312, R659180000313, R659180000314, R659180000315, R659180000316, R659180000317, R659180000318, R659180000319, R659180000321, R659180000322, R659180000323, R659180000324, R659180000325, R659180000326, R659180000327, R659180000328, R659180000329, R659180000330, R659180000331, R659180000332, R659180000333, R659180000334, R659180000335, R659180000336, R659180000337, R659180000338, R659180000339, R659180000340, R659180000341, R659180000342, R659180000343, R659180000344, R659180000345, R659180000346, R659180000347, R659180000348, R659180000349, R659180000350, R659180000352, R659180000353, R659180000354, R659180000355, R659180000356, R659180000357, R659180000358, R659180000359, R659180000360, R659180000361, R659180000362, R659180000363, R659180000364, R659180000365, R659180000366, R659180000367, R659180000368, R659180000369, R659180000370, R659180000371, R659180000372, R659180000373, R659180000374, R659180000375, R659180000376, R659180000377, R659180000378, R659180000379, R659180000380, R659180000381, R659180000382, R659180000383, R659180000384, R659180000385, R659180000386, R659180000387, R659180000388, R659180000389, R659180000390, R659180000391, R659180000392, R659180000393, R659180000394, R659180000395, R659180000396, R659180000397, R659180000398, R659180000399, R659180000402, R659180000403, R659180000404, R659180000405, R659180000406, R659180000407, R659180000408, R659180000409, R659180000410, R659180000411, R659180000412, R659180000413, R659180000414, R659180000415, R659180000416, R659180000417, R659180000418, R659180000419, R659180000420, R659180000422, R659180000423, R659180000424, R659180000425, R659180000426, R659180000427, R659180000428, R659180000430, R659180000431, R659180000432, R659180000433, R659180000435, R659180000436, R659180000438, R659180000442, R659180000445, R65918000084, R6591800022, R65918000314, R6591800038,2, RZ6591800026, Z651165P024, Z654587P006, Z654587P007, Z654587P018, Z654587P019, Z6591800013, Z66238300002, R659180000164.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore

device · product 9 of 9

BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes

Z-0074-2020
Recall number
Z-0074-2020
Initiated
August 19, 2019
Classification
Class II
Status
Terminated
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.

Code information

BD FACSLyric Flow Cytometer serial numbers: R663029000001, R663029000002, R663029000003, R663029000004, R663029000005, R663029000006, R663029000007, R663029000008, R663029000010, R663029000011, R663029000012, R663029000014, R663029000015, R663029000016, R663029000017, R663029000018, R663029000021, R663029000025, R663029000031, R659180000136, R659180000160, R659180000238.

Distribution pattern

U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore