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Randox Laboratories Ltd. recalls RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Recalled December 8, 2021 · FDA recall Z-0328-2022 · Randox Laboratories
Hazard
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 · FDA Class II
Units
15 kits
Sold at
US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Description
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
Product
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →