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FDANovember 13, 2020device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273209303

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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