Randox Laboratories Ltd. recalls Calibration Serum Level 3 CAL2351
- Recall date
- November 20, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0752-2024
- FDA classification
- Class II
- Brand / firm
- Randox Laboratories Ltd.
- Sold / distributed
- US Nationwide and Puerto Rico.
Why it was recalled
CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Calibration Serum Level 3 CAL2351
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