medical Class II Updated 2019-10-16

Becton, Dickinson and Company, BD Biosciences recalls BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, RE

Recalled Product

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

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