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FDAMarch 14, 2018device

Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multiplexed in-vitro diagnostic test intended for use with the Accelerate Pheno system.

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

The hazard

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

What to do

FDA enforcement status: Terminated

Brands named

accelerate diagnosticsaccelerate

Recall history

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

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