FDAAugust 19, 2019device

BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

becton dickinson and company bd biosciencesbectonbecton dickinson

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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