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.
Reported: May 2, 2018 Initiated: March 14, 2018 #Z-1529-2018
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).
Details
- Recalling Firm
- Accelerate Diagnostics Inc
- Units Affected
- 95 kits
- Distribution
- Distributed to IL, TX, CA, SC, and DE.
- Location
- Tucson, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accelerate Diagnostics Inc. Units affected: 95 kits.
Why was this product recalled? ▼
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1529-2018.
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