BD FACSLyric Flow Cytometer recall
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
Why was BD FACSLyric Flow Cytometer recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 236
- Distribution
- 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
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)