Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Accelerate PhenoTest BC kit Recalled by Accelerate Diagnostics Inc Due to The kits may produce an elevated rate of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Accelerate Diagnostics Inc directly.
Affected Products
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.
Quantity: 95 kits
Why Was This Recalled?
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Where Was This Sold?
This product was distributed to 5 states: CA, DE, IL, SC, TX
About Accelerate Diagnostics Inc
Accelerate Diagnostics Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report