Drug recall
VITEK2 GP-ID, REF 21342 IVD
FDA recall event 78288 · Class II · Biomerieux Inc
Key facts
| Event ID | 78288 |
|---|---|
| Recall numbers | Z-0074-2018 |
| Recalling firm | Biomerieux Inc |
| Product type | Devices |
| Products | VITEK2 GP-ID, REF 21342 IVD |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3)… |
| Initiation date | Oct 11, 2017 |
| Report date | Nov 15, 2017 |
| Termination date | Nov 9, 2020 |
| 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: