Reported Dec 8, 2021 · Terminated

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

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

Is this the product you have?

  • RANDOX CHOL-cholesterol (total) test system intended to measure
  • cholesterol in plasma and serum REFCH200
Lot codes and dates
  • Lot Numbers/Exp Date
    • 559344 28th June 2022
    • 572730 28th July 2023
  • GTIN05055273201130
Amount recalled
15 kits

Where it was sold

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 9, 2023 · Data as of Sep 19, 7:33 PM UTC

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