Reported Dec 16, 2020 · Terminated

Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine…

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 Mg R1 - Product UsageFor the quantitative in vitro determination of Magnesium in serum
  • plasma and urine Catalogue NumberMG3880
Lot codes and dates
  • Lot Number539734
  • Exp Date28
  • March 2022 UDI05055273204629
Amount recalled
1 kit

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by approximately -30% for Serum/ Plasma and -50% for Urine

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 Apr 1, 2021 · Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.