Z-0896-2022Class II

C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and...

Name: Z-0896-2022 C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and...
Creator: DRG International, Inc.
Published: 2021-12-21
License: https://open.fda.gov/license/

DRG International, Inc. / initiated 2021-12-21 / Terminated

FDA source

DRG International, Inc. began a recall of C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293 on 2021-12-21. FDA classified it as Class II and gives the reason as "ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0896-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-21
Posted: 2022-04-07
Terminated: 2024-02-12
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
Product code: JKD Radioimmunoassay, C-Peptides Of Proinsulin
Reason for recall: ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
FDA 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: [email protected] and copy [email protected].
Quantity in commerce: 3 Kits
Distribution: NY
Product codes and lots: Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0896-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0896-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-07

Product code JKD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)