Z-0546-2021Class II

Randox Mg R1 -

Name: Z-0546-2021 Randox Mg R1 -
Creator: Randox Laboratories Ltd.
Published: 2020-11-13
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2020-11-13 / Terminated

FDA source

Randox Laboratories Ltd. began a recall of Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880 on 2020-11-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0546-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-13
Posted: 2020-12-08
Terminated: 2021-04-01
Recalling firm: Randox Laboratories, Limited
Product: Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880
Product code: JGJ Photometric Method, Magnesium
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 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. [email protected] within five working days. Questions or concerns, please contact Randox Technical Services.
Quantity in commerce: 1 kit
Distribution: US Nationwide distribution in the states of GA, NJ.
Product codes and lots: Lot Number: 539734, Exp Date: 28 March 2022 UDI: 05055273204629

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0546-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0546-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-08
Z-0547-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-08

Product code JGJ

K974606Class IRandox MagnesiumRandox Laboratories, Ltd. / cleared 1998-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)