Recall Z-0896-2022 ยท JKD Radioimmunoassay, C-Peptides Of Proinsulin
DRG International, Inc.
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
| Date | Dec 21, 2021 |
| Status | Terminated |
| Reason | ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible |
| Root cause | Under Investigation by firm |
| Action | DRG issued letter via email on 12/28/21. Letter states reason for recall, health risk and Action to be taken by distributors and end-users: Please check your inventory for the respective lot, stop using these kits immediately and promptly quarantine these products. Only if you faced above mentioned issue of SO OD <1.2, please ask for replacement of the kits that were affected and provide your data. All unused kits of the affected lot will be replaced.Please reply immediately upon checking your stock/use to this notice to confirm. All replies should be received at once OR by January 7th, 2022. |
| Quantity | 3 Kits |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.