Device product
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Z-0546-2021
Product summary
- Event
- Event 86827
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 kit
- Official record key
device-enforcement:Z-0546-2021
Official wording
Reason: 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
Code information: Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
Distribution pattern: US Nationwide distribution in the states of GA, NJ.
Derived failure modes
-
Unknown
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