API 50 CH — Class II medical device recall Z-0243-2022
Terminated recall by bioMerieux, Inc., reported 2021-11-24, distributed in NY, SD, WI. There is potential to provide an incorrect organism identification.
| Recall number | Z-0243-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | bioMerieux, Inc., Durham, NC, United States |
| Recall initiated | 2021-09-30 |
| Classified | 2021-11-17 |
| Reported by FDA | 2021-11-24 |
| Terminated | 2024-01-18 |
| Distributed | NY, SD, WI |
| Quantity | 1,382 kits |
| UPC / GTIN / UDI-DI | 03573026087401 |
| Lot numbers | 1008679230 |
| Model numbers | 50300 |
Product
API 50 CH, Model 50300
Reason for recall
There is potential to provide an incorrect organism identification.
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-0243-2022. 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.