MAGNESIUM (Mg) recallZ-0546-2021 · Randox Laboratories Ltd. · initiated Nov 13, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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. [email protected] within five working days. Questions or concerns, please contact Randox Technical Services.
Recall details
- Recall number
- Z-0546-2021
- Status
- Terminated
- Initiated by the company
- Nov 13, 2020
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1 kit
- Product code
- JGJ
- FDA submissions
- K974606
- Distribution
- US Nationwide distribution in the states of GA, NJ.
Product description
Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Code information (models, lots, serial numbers)
Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MAGNESIUM (Mg) MG3880Randox Laboratories Limited · Photometric Method, Magnesium1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 86827).
- Z-0547-2021 · TerminatedRandox Rx Series Mg - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG8326
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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