Reported Jul 27, 2022 · Terminated
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number:…
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North), N/A · N/A
Is this the product you have?
- Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma
- Catalog NumberCH2O0
- Lot codes and dates
- GTIN05055273201130
- Lot Number586177
- Expiry Date28th Jan 2024
- Amount recalled
- 15 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Product fails to meet the performance claims quoted on the kit insert: Manual Procedure 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; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
This product could cause temporary or reversible health problems — stop using it.
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