Device product
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293
Z-0896-2022
Product summary
- Event
- Event 89680
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 Kits
- Official record key
device-enforcement:Z-0896-2022
Official wording
Reason: ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible
Code information: Lot# / Expiration dates: 20K061 / 2022-06-30 20K071 / 2022-07-31 20K081 / 2022-08-31
Distribution pattern: NY
Derived failure modes
-
Unknown
ODs of the standards too low(< 0.6 ODmax) may cause invalid runs, delayed patient results are possible