Class II — IMMUNDIAGNOSTIK, Inc
| Recalling firm | Immundiagnostik, Inc. |
|---|---|
| Registered facility | IMMUNDIAGNOSTIK, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Marketed without a 510k |
| Product | 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 |
| Quantity | 88 units |
| Distribution | US Nationwide Distribution: CA, IL, NC, NH, OR |
| Initiated | 2023-03-27 |
| Classified | 2023-05-17 |
| Recall number | Z-1603-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IMMUNDIAGNOSTIK, Inc (Z-1603-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92131/
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