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Accelerate Diagnostics Inc recalls Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Accelerate Diagnostics, Tucson, AZ. A mult
Recalled May 2, 2018 · FDA recall Z-1529-2018 · Accelerate Diagnostics
Hazard
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU). · FDA Class II
Units
95 kits
Sold at
Distributed to IL, TX, CA, SC, and DE.
Description
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
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.
Manufacturer(s)
Accelerate Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →