FDA recall Z-0896-2022

DRG International, Inc. · Class II · device

Product

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

Distribution

NY

Key facts

Status: Terminated
Initiation date: 2021-12-21
Report date: 2022-04-13
Termination date: 2024-02-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Springfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0896-2022