Accelerate PhenoTest BC kit REF 10101018 — Class II medical device recall Z-0345-2023
Ongoing recall by Accelerate Diagnostics Inc, reported 2022-12-07, distributed in AR, CA, DC, FL, GA, IA, IL, IN…. Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting
| Recall number | Z-0345-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accelerate Diagnostics Inc, Tucson, AZ, United States |
| Recall initiated | 2022-10-17 |
| Classified | 2022-11-30 |
| Reported by FDA | 2022-12-07 |
| Distributed | 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, WV |
| Countries outside the US | AE, DE, ES, IT, KW, LV, PL, PT, RO, SA |
| Quantity | 200 kits |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 00862011000307 |
| Lot numbers | 5549A, 5566A, 5588A, 5606A, 5612A |
| Model numbers | 10101018 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0345-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.