Z-0725-2017Class II

Magnesium on RX Imola analyser IVD

Name: Z-0725-2017 Magnesium on RX Imola analyser IVD
Creator: Randox Laboratories, Limited
Published: 2016-04-14
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2016-04-14 / Terminated / root cause: design

FDA source

Randox Laboratories, Limited began a recall of Magnesium on RX Imola analyser IVD on 2016-04-14. FDA classified it as Class II and gives the reason as "According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0725-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Posted: 2016-12-08
Terminated: 2017-09-19
Recalling firm: Randox Laboratories, Limited
Product: Magnesium on RX Imola analyser IVD
Product code: JGJ Photometric Method, Magnesium
Reason for recall: According to the firm, Carry over was observed when the amylase or pancreatic amylase test is run directly before or after the Magnesium assay. An update is required to the RX Imola analyser running order and an acid wash recommended when setting up the magnesium assay. A correction was made to the IFU for the Magnesium assay and all RX Imola customers in the USA were contacted with the updated instruction.
Root cause tag: design
FDA root cause: Device Design
Action: Randox sent an Urgent Field Safety Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review and update Rx Imola running order where required. Rework any remaining stock with updated IFU and Important Notice. Complete and return the vigilance response section of the form to [email protected].
Quantity in commerce: 15
Distribution: Nationwide Distribution The product was only distributed to US Consignees.
Product codes and lots: reagent: MG3880 analyser: RX4900

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0725-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0725-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-08

Product code JGJ

K052914Class IIRx ImolaRandox Laboratories, Ltd. / cleared 2006-03-31

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)