FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
- Recall number
- Z-0546-2021
- Recalling firm
- Randox Laboratories Ltd.
- Product
- Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
- Status
- Terminated
- Initiated
- 2020-11-13
- Posted
- not on file
- Terminated
- 2021-04-01
- 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 within five working days. Questions or concerns, please contact Randox Technical Services.
- Quantity
- 1 kit
- Distribution
- US Nationwide distribution in the states of GA, NJ.
- Lot, serial or model codes
- Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629
- 510(k) numbers
- ["K974606"]
- PMA numbers
- not on file
- Product code
- JGJ
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28