DRG International, Inc. Recall 89680
Description: C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
DRG International, Inc. Recall 89680 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0896-2022 |
| Event ID | 89680 |
| Event Description | C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293 |
| Product Type | Devices |
| Distribution | NY |
| Quantity | 3 Kits |
| Recall Reason | ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible |
| Device Classification | 20220413 |
| Device Code Info | Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31 |
| Center Classification Date | 20220407 |
| Recall Initiation Date | 20211221 |
| Recalling Firm | DRG International, Inc. |
| Initial Notification | |
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