# FDA recall Z-0345-2023

> **Accelerate Diagnostics Inc** · Class II · device recall initiated 2022-10-17.

## Product

Accelerate PhenoTest BC kit REF 10101018

## Reason for recall

Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for Staphylococcus aureus and Streptococcus spp.

## Distribution

U.S.: AR, CA, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, MT, NC, ND, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV.  O.U.S.: Germany, Italy, Kuwait, Latvia, Poland, Portugal, Romania, Saudi Arabia, Spain, and United Arab Emirates

## Key facts

- **Recall number:** Z-0345-2023
- **Recalling firm:** Accelerate Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-17
- **Report date:** 2022-12-07

- **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-0345-2023

## Citation

> AI Analytics. FDA recall Z-0345-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0345-2023. Source: US FDA. Licensed CC0.

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