Z-1369-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2024
- Initiation Date
- February 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 666 units
Product Description
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Reason for Recall
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Distribution Pattern
US Nationwide distribution in the states of CA, IN.
Code Information
GTIN: 05055273207439 (1) Batch 600957 Lot 1378CY - 1382CY (2) Batch 621809, 621815 Lot 1403CY - 1407CY (3) Batch 650533 Lot 1414CY - 1418CY