Drug recall
API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
FDA recall event 91148 · Class II · Biomerieux Inc
Key facts
| Event ID | 91148 |
|---|---|
| Recall numbers | Z-0783-2023, Z-0784-2023, Z-0785-2023, Z-0786-2023, Z-0787-2023, Z-0788-2023, Z-0789-2023, Z-0790-2023, Z-0791-2023, Z-0792-2023, Z-0793-2023, Z-0794-2023 and 82 more |
| Recalling firm | Biomerieux Inc |
| Product type | Devices |
| Products | API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210, API 20 E 25 STRIPS, CATALOG 20100, API JAMES 2AMP, CATALOG 70542, API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300, API NIT1 NIT2 REAGENTS, CATALOG 70442 and 89 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Initiation date | Nov 9, 2022 |
| Report date | Jan 11, 2023 |
| City | Hazelwood |
| State | MO |
| Country | United States |
| FEI number | 1950204 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: