Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0546-2021 — Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880

U.S. FDA — Device Enforcement · Ireland · 2020-11-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0546-2021
Date of alert
2020-11-13
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
Randox Laboratories Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055273204629
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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