medical Class II Updated 2018-05-02

Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit, Ref #10101018. The firm name o

Recalled Product

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.

Hazard / Issue

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

Issued by

FDA

Affected States: IL, TX, CA, SC, DE
Lot/Code Info: Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.
View official government recall

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