Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
Reported: April 3, 2024 Initiated: February 14, 2024 #Z-1369-2024
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
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 666 units
- Distribution
- US Nationwide distribution in the states of CA, IN.
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699. Recalled by Randox Laboratories Ltd.. Units affected: 666 units.
Why was this product recalled? ▼
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2024. Severity: Moderate. Recall number: Z-1369-2024.
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