Device product
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Z-1369-2024
Product summary
- Event
- Event 94088
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 666 units
- Official record key
device-enforcement:Z-1369-2024
Official wording
Reason: Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Code information: GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY
Distribution pattern: US Nationwide distribution in the states of CA, IN.
Derived failure modes
-
Unknown
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods