Z-0546-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2020
- Initiation Date
- November 13, 2020
- Termination Date
- April 1, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 kit
Product Description
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 Pattern
US Nationwide distribution in the states of GA, NJ.
Code Information
Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629