FDAClass IIDecember 16, 2020

Randox recall

Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326

Why was Randox recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 539770 Exp. Date : 28 March 2022 UDI: 05055273209303

Product
Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
Recalling firm
Randox Laboratories Ltd.
Quantity
4 kits
Distribution
US Nationwide distribution in the states of GA, NJ.
Recall date
December 16, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls