FDA recall Z-1529-2018

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 for recall

The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification probe (SAU).

Distribution

Distributed to IL, TX, CA, SC, and DE.

Key facts

Status

Terminated

Initiation date

2018-03-14

Report date

2018-05-02

Termination date

2023-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tucson, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1529-2018