Becton, Dickinson and Company, BD Biosciences recalls BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF

Hazard / Issue

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.

Issued by

FDA

Affected States: 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

Lot/Code Info: 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.