Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

FDA Recall Z-0896-2022 · Posted None

Recalling FirmDRG International, Inc.
Recall StatusTerminated
Product CodeJKD
Date Initiated2021-12-21
Date Terminated2024-02-12
Product Quantity3 Kits

Reason for Recall

ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible

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].

Root Cause

Under Investigation by firm

Distribution Pattern

NY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑