Recall Z-0546-2021
Randox Laboratories Ltd. · initiated November 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Codes / lots: Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
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
FDA-determined 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.
Details
- Recall number
- Z-0546-2021
- Initiated
- November 13, 2020
- Terminated
- April 1, 2021
- Product code
- JGJ – Photometric Method, Magnesium
- Quantity
- 1 kit
- Distribution
- US Nationwide distribution in the states of GA, NJ.
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0547-2021 Class II | Randox Rx Series Mg - Product Usage: For the quantitative in vitro determination of…Failing to meet the linearity performance claims quoted on the kit inserts-The linearity is reduced by… | 11/13/2020Terminated |