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FDAOctober 17, 2022device

Accelerate PhenoTest BC kit REF 10102018

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

The hazard

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

What to do

FDA enforcement status: Ongoing

Brands named

accelerate diagnosticsaccelerate

UPCs

00862011000369

Recall history

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

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