FDA-Device2021-12-08Class II
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Randox Laboratories Ltd.
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
Sold states
US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
Affected count
15 kits
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0328-2022Don't want to check this manually?
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