Randox Laboratories Ltd. recalls Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated an…
- Recall date
- February 14, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1369-2024
- FDA classification
- Class II
- Brand / firm
- Randox Laboratories Ltd.
- Sold / distributed
- US Nationwide distribution in the states of CA, IN.
Why it was recalled
Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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