FDA Device recall Z-0896-2022
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine by Drg International, citing ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0896-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-21 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Drg International |
| Distribution | NY |
Product
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Reason
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Identifiers
| code_info | Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0896-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.