DRG International, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0896-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 21, 2021

Date Posted: April 13, 2022

Recall Number: Z-0896-2022

Event ID: 89680

Reason for Recall:

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

Status: Terminated

Product Quantity: 3 Kits

Code Information:

Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated