Accelerate PhenoTest BC kit — Class II medical device recall Z-1529-2018
Terminated recall by Accelerate Diagnostics Inc, reported 2018-05-02, distributed in CA, DE, IL, SC, TX. The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus identification pro
| Recall number | Z-1529-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accelerate Diagnostics Inc, Tucson, AZ, United States |
| Recall initiated | 2018-03-14 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2023-01-17 |
| Distributed | CA, DE, IL, SC, TX |
| Quantity | 95 kits |
| Pathogens | staphylococcus |
| Lot numbers | 2880A, 2885A, 2886A, 2887A |
| Model numbers | 10101018 |
| Expiration dates | 2018-09-18 |
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).
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-1529-2018. 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.