Drug recall
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of…
FDA recall event 92131 · Class II · IMMUNDIAGNOSTIK, Inc
Key facts
| Event ID | 92131 |
|---|---|
| Recall numbers | Z-1603-2023 |
| Recalling firm | IMMUNDIAGNOSTIK, Inc |
| Product type | Devices |
| Products | Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Marketed without a 510k |
| Initiation date | Mar 27, 2023 |
| Report date | May 24, 2023 |
| City | Manchester |
| State | NH |
| Country | United States |
| FEI number | 3015189693 |
At a glance
- 1–9 Products in this recall
- None 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: