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 Mg R1 Kit: Reduced Magnesium Testing Accuracy Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63918-randox-mg-r1-kit-reduced-magnesium-testing-accuracy-risk. Based on FDA recall #Z-0546-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0546-2021%22&limit=1).
The FDA announced on 2020-11-13 that Randox Laboratories Ltd. is recalling its Randox Mg R1 in vitro diagnostic kit due to linearity performance failures. The agency classified the recall as Class II.
How to tell if you have it
Brand: Randox
Product: Randox Mg R1
Catalogue Number: MG3880
Lot Number: 539734
Expiration Date: 28 March 2022
UDI: 05055273204629
The hazard
According to the FDA, the kits fail to meet linearity performance claims quoted on the kit inserts. The linearity is reduced by approximately -30% for Serum/Plasma and -50% for Urine.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Recent brand recalls include a 2024-06-07 Cystatin C Reagent recall for missing FDA 510(k) and a 2024-04-05 Evidence MultiSTAT Software recall for light leak risk. Other recent recalls of similar products include Siemens Atellica CH Urine Albumin Recall (2026-07-06) and Medline Convenience Kits Recall (2026-01-07).
How to tell if you have this one
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.
Brand
Randox
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of GA, NJ.
Recall number
Product, codes & lots
Quantity
Z-0546-2021
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880; Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
1 kit
Z-0547-2021
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326; Lot Number: 539770 Exp. Date : 28 March 2022 UDI: 05055273209303
4 kits
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the catalogue number MG3880 and lot number 539734 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of GA, NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, New Jersey.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0546-2021 (November 13, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0546-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.