Randox recalls Mg test kits that may show inaccurate magnesium levels in serum/plasma due to reduced linearity. Affected kits have specific catalog and lot numbers.
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 Mg test kits that may give inaccurate magnesium results for serum and plasma. This could lead to incorrect health assessments if used without proper calibration.
The test kits may show results that are up to 30% less accurate for serum/plasma and 50% less accurate for urine due to reduced linearity. This means magnesium levels could be misreported, potentially affecting diagnosis and treatment decisions.
Lab users who purchased Randox Rx Series Mg kits with catalog number MG8326 and lot number 539770 (expired 28 March 2022) are affected. Most at risk are healthcare professionals using these kits for clinical testing.
Check for catalog number MG8326 and lot number 539770 on the kit packaging. These kits were sold with expiration date 28 March 2022.
Verify the catalog number (MG8326) and lot number (539770) on the kit packaging.
The test kits may show reduced linearity, meaning magnesium results could be up to 30% less accurate for serum/plasma and 50% less accurate for urine.
The recall record does not specify a remedy, so check the kit details and contact Randox if you have concerns.
The recall is for potential inaccuracy in test results, not a physical hazard. There is no risk of injury from using the kits.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0547-2021 — Randox Randox Hello, I own a Randox that is covered by recall Z-0547-2021 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.
