Z-0073-2020 Class II Terminated
FDA device recall Z-0073-2020 was initiated by Becton, Dickinson and Company, BD Biosciences on August 19, 2019 and is designated Class II. 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… The recall status is terminated (terminated April 12, 2024). Affected quantity: 236.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- August 19, 2019
- Termination Date
- April 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 236
Product Description
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
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.
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
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.