Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
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
What You Should Do
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.
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Products
- Brand
- Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
- UPC
- Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
Units Affected
1 kit