Recall Z-0896-2022— DRG International, Inc.

Name: FDA recall Z-0896-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-21

Class II · Terminated

Class II FDA medical device recall by DRG International, Inc., initiated 2021-12-21, terminated 2024-02-12. FDA's recall record names no specific 510(k) clearance for this event. Product: C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293. Reason: ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible.

Recalling firm: DRG International, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-12-21
Terminated: 2024-02-12
Firm location: Springfield, NJ, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.