Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
This recall has been terminated (originally issued November 13, 2020).
- Recall Initiated
- November 13, 2020
- Terminated
- April 1, 2021
- Recall Number
- Z-0546-2021
- Quantity
- 1 kit
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
Root Cause
Under Investigation by firm
Action Taken
Randox issued Urgent Medical Device Correction letter via e-mail to US Customers on 13 November 2020 stating reason for recall, health risk and action to take: Discontinue use of and discard any of the above immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to technical. services@randox.com within five working days. Questions or concerns, please contact Randox Technical Services.