Z-1529-2018 Class II Terminated

Recalled by Accelerate Diagnostics Inc — Tucson, AZ

Recall Details

Product Type
Devices
Report Date
May 2, 2018
Initiation Date
March 14, 2018
Termination Date
January 17, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
95 kits

Product Description

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 for Recall

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

Distribution Pattern

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

Code Information

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