Recall Z-0546-2021 ยท JGJ Photometric Method, Magnesium
Randox Laboratories Ltd.
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
| Date | Nov 13, 2020 |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 1 kit |
| Distribution | US Nationwide distribution in the states of GA, NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974606 | RANDOX MAGNESIUM Randox Laboratories, Ltd., Feb 12, 1998 |