FDA Medical Device Recalls (openFDA)
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 number
- Z-0896-2022
- Recalling firm
- DRG International, Inc.
- Product
- C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
- Status
- Terminated
- Initiated
- 2021-12-21
- Posted
- not on file
- Terminated
- 2024-02-12
- 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. 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.
- Quantity
- 3 Kits
- Distribution
- NY
- Lot, serial or model codes
- Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JKD
- Firm FEI
- 2245285
- Firm city
- Springfield
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28