# FDA recall Z-1529-2018

> **Accelerate Diagnostics Inc** · Class II · device recall initiated 2018-03-14.

## 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

- **Recall number:** Z-1529-2018
- **Recalling firm:** Accelerate Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1529-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1529-2018. Source: US FDA. Licensed CC0.

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