medical Class II Updated 2019-10-16

Becton, Dickinson and Company, BD Biosciences recalls BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF

Recalled Product

BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, 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: R654587000008, R654587000009, R654587000010, R654587000011, R654587000024, R654587000026, R654587000027, R654587000028, R654587000029, R654587000030, R654587000031, R654587000032, R654587000033, R654587000034, R654587000035, R654587000036, R654587000037, R654587000038, R654587000039, R654587000040, R654587000041, R654587000042, R654587000043, R654587000044, R654587000045, R654587000046, R654587000047, R654587000048, R65458700020, Z654587P027.

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