medical Class II Updated 2019-10-16

Becton, Dickinson and Company, BD Biosciences recalls BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF

Recalled Product

BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, 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: R651165000010, R651165000023, R651165000024, R651165000025, R651165000026, R651165000027, R651165000028, R651165000029, R651165000030, R651165000031, R651165000032, R651165000033, R651165000034, R651165000035, R651165000036, R651165000037, R651165000038, R651165000039, R651165000040, R651165000041, R651165000042, R651165000043, R651165000044, R651165000045, R651165000046, R651165000048, R651165000049, R651165000050, R651165000051, R651165000052, R651165000053, R651165000054, R651165000055, R651165000057, R651165000058, R651165000060.
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