C-Peptide ELISA : IVD measurement of C-Peptide in serum — Class II medical device recall Z-0896-2022
Terminated recall by DRG International, Inc., reported 2022-04-13, distributed in NY. ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
| Recall number | Z-0896-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG International, Inc., Springfield, NJ, United States |
| Recall initiated | 2021-12-21 |
| Classified | 2022-04-07 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-02-12 |
| Distributed | NY |
| Quantity | 3 kits |
| Lot numbers | 20K061, 20K071, 20K081 |
| Model numbers | EIA-1293 |
Product
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Reason for recall
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
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-0896-2022. 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.