Recall archive / FDA device enforcement
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalo... — FDA record Z-0896-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 21, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- DRG International, Inc.
- Quantity
- 3 Kits
- Agency-reported status
- Terminated
- Source record identifier
- Z-0896-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
NY
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Dec 21, 2021
- Center classification date
- Apr 7, 2022
- Termination date
- Feb 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.