FDA-Device2018-05-02Class II
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.
Accelerate Diagnostics Inc
Hazard
The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).
Sold states
Distributed to IL, TX, CA, SC, and DE.
Affected count
95 kits
Manufactured in
3950 S Country Club Rd Ste 470, N/A, Tucson, AZ, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2018Don't want to check this manually?
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