C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
- Company
- Drg International, Inc.
- Recall Initiated
- December 21, 2021
- Terminated
- February 12, 2024
- Recall Number
- Z-0896-2022
- Quantity
- 3 Kits
- Firm Location
- Springfield, NJ
Reason for Recall
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Distribution
NY
Lot / Code Info
Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
Root Cause
Under Investigation by firm
Action Taken
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. We sincerely apologize for the inconvenience this may have caused you and/or your Customer. Reply to email: qa@drg-international.com and copy drgsupport@drginternational.com.