medical Class II Updated 2020-12-16

Randox Laboratories Ltd. recalls Randox Mg R1 - Product Usage: For the quantitative in vitro

Recalled Product

Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
View official government recall

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