DRG International, Inc. C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Brand
DRG International, Inc.
Lot Codes / Batch Numbers
Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
Products Sold
Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
DRG International, Inc. is recalling C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) due to ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NY
Page updated: Jan 10, 2026