FDA-Device2020-12-16Class II
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Randox Laboratories Ltd.
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
Sold states
US Nationwide distribution in the states of GA, NJ.
Affected count
1 kit
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0546-2021Don't want to check this manually?
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