FDA recall Z-0546-2021

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of GA, NJ.

Key facts

Status

Terminated

Initiation date

2020-11-13

Report date

2020-12-16

Termination date

2021-04-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0546-2021