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.

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

Code information: Lot numbers 2880A, 2885A, 2886A, and 2887A, all with exp. date of 9/18/2018.

Distribution pattern: Distributed to IL, TX, CA, SC, and DE.