Recall Z-1529-2018— Accelerate Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Accelerate Diagnostics Inc, initiated 2018-03-14, terminated 2023-01-17. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU)..
- Recalling firm
- Accelerate Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-14
- Terminated
- 2023-01-17
- Firm location
- Tucson, AZ, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.