Recall Z-1369-2024— Randox Laboratories Ltd.
Class II · Ongoing
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2024-02-14. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods.
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-14
- Firm location
- Crumlin (North), N/A, Ireland
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.