Randox Laboratories, Limited: Medical Device Recall in 2016 - (Recall #: Z-0725-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Magnesium on RX Imola analyser IVD

Product Classification:

Class II

Date Initiated: April 14, 2016

Date Posted: December 14, 2016

Recall Number: Z-0725-2017

Event ID: 75263

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.

Status: Terminated

Product Quantity: 15

Code Information:

reagent: MG3880 analyser: RX4900

Distribution Pattern:

Nationwide Distribution The product was only distributed to US Consignees.

Voluntary or Mandated:

Voluntary: Firm initiated