medical Class II Updated 2019-10-16

Becton, Dickinson and Company, BD Biosciences recalls BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF

Recalled Product

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, 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: R651164000007, R651164000016, R651164000017, R651164000019, R651164000020, R651164000021, R651164000022, R651164000023, R651164000024, R651164000025, R651164000026, R651164000027, R651164000028, R651164000029, R651164000030, R651164000031, R651164000032, R651164000033, R651164000034, R651164000035, R651164000036.

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