Randox Laboratories Ltd. recalls RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
- Recall date
- November 1, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0328-2022
- FDA classification
- Class II
- Brand / firm
- Randox Laboratories Ltd.
- Sold / distributed
- US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Why it was recalled
When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
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