Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A multipl…

Recall date

March 14, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1529-2018

FDA classification

Class II

Brand / firm

Accelerate Diagnostics Inc

Sold / distributed

Distributed to IL, TX, CA, SC, and DE.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.