Drug recall
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
FDA recall event 89041 · Class II · Biomerieux Inc
Key facts
| Event ID | 89041 |
|---|---|
| Recall numbers | Z-0422-2022 |
| Recalling firm | Biomerieux Inc |
| Product type | Devices |
| Products | RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test. |
| Initiation date | Nov 9, 2021 |
| Report date | Jan 5, 2022 |
| Termination date | Feb 10, 2025 |
| City | Hazelwood |
| State | MO |
| Country | United States |
| FEI number | 1950204 |
At a glance
- 1–9 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: