Randox recalls Mg R1 kits for inaccurate magnesium testing in serum/plasma/urine due to linearity issues. Affected kits may give unreliable results.
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
Randox is recalling its Mg R1 magnesium testing kits because they may provide inaccurate results for serum, plasma, and urine tests. This could lead to incorrect health assessments if used without proper calibration.
The kits may show reduced linearity in testing, meaning results for serum and plasma are about 30% less accurate and urine results are 50% less accurate than claimed. This could lead to incorrect health assessments if used without proper calibration.
People using Randox Mg R1 kits for magnesium testing in labs or clinical settings. Those with medical devices requiring precise magnesium measurements are most at risk.
Check for the catalogue number MG3880 and lot number 539734 (expiring 28 March 2022) on the kit packaging. The unique device identifier (UDI) is 05055273204629.
Verify the catalogue number MG3880 and lot number 539734 on the kit packaging.
The kits may provide inaccurate magnesium test results due to reduced linearity in serum/plasma (30% less accurate) and urine (50% less accurate).
Look for catalogue number MG3880 and lot number 539734 (expiring 28 March 2022) on the kit packaging.
No action is required as the recall is for potential accuracy issues, not immediate safety hazards.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0546-2021 — Randox Randox Hello, I own a Randox that is covered by recall Z-0546-2021 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
