Randox Mg R1 Magnesium Test Kit Recalled for Linearity Performance Failure
Randox Laboratories is recalling Randox Mg R1 kits due to reduced linearity performance, which may affect the accuracy of magnesium test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a performance defect leading to potential inaccurate results, which aligns with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls without reported harm.
Plain-English summary
Randox Laboratories Ltd. is recalling Randox Mg R1 kits, used for the quantitative in vitro determination of Magnesium in serum, plasma, and urine. The recall is due to the product failing to meet the linearity performance claims stated on the kit inserts.
The linearity of the affected kits is reduced by approximately -30% for Serum/Plasma and -50% for Urine. This performance issue may result in inaccurate test results. The affected product is identified by Lot Number 539734 and an expiration date of 28 March 2022. The UDI is 05055273204629.
The product was distributed nationwide in the United States, specifically in the states of Georgia (GA) and New Jersey (NJ). Users of the affected kits should stop using them and contact Randox Laboratories for further instructions or a replacement.
The recalled product
- Product
- Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 539734
- Exp Date: 28 March 2022 UDI: 05055273204629
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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