Randox Rx Series Mg Magnesium Test Kits Recalled for Performance Failure
Randox Laboratories is recalling four kits of the Rx Series Mg Magnesium test due to reduced linearity performance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (inaccurate diagnostic results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Randox Laboratories Ltd. is recalling four kits of the Randox Rx Series Mg, a medical device used for the quantitative in vitro determination of Magnesium in serum, plasma, and urine. The affected product is identified by Lot Number 539770, with an expiration date of 28 March 2022, and UDI 05055273209303.
The recall was initiated because the product failed to meet the linearity performance claims stated on the kit inserts. Specifically, the linearity is reduced by approximately -30% for Serum/Plasma and -50% for Urine. The agency has classified this recall as Class II.
The affected kits were distributed nationwide in the United States, specifically in the states of Georgia (GA) and New Jersey (NJ). Users of these kits should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- Affected units
- 4
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 (1)
- Lot Number: 539770 Exp. Date : 28 March 2022 UDI: 05055273209303
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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