Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay… — Class II medical device recall Z-1603-2023
Completed recall by IMMUNDIAGNOSTIK, Inc, reported 2023-05-24, distributed nationwide. Marketed without a 510k
| Recall number | Z-1603-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | IMMUNDIAGNOSTIK, Inc, Manchester, NH, United States |
| Recall initiated | 2023-03-27 |
| Classified | 2023-05-17 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Quantity | 88 units |
| UPC / GTIN / UDI-DI | 04050598000582 |
| Lot numbers | 220706, 221122, 221124, 230102 |
| Expiration dates | 2024-05-04, 2024-06-07, 2025-07-29, 2025-10-24 |
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
Reason for recall
Marketed without a 510k
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1603-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.