Z-1529-2018 Class II Terminated
FDA device recall Z-1529-2018 was initiated by Accelerate Diagnostics Inc on March 14, 2018 and is designated Class II. Reason for recall: The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). The recall status is terminated (terminated January 17, 2023). Affected quantity: 95 kits.
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.