Randox Laboratories Ltd.: Medical Device Recall in 2022 - (Recall #: Z-0363-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

Product Classification:

Class II

Date Initiated: November 1, 2022

Date Posted: December 14, 2022

Recall Number: Z-0363-2023

Event ID: 91097

Reason for Recall:

Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results

Status: Terminated

Product Quantity: 20 kits US in total

Code Information:

GTIN: 05055273204001 All lots

Distribution Pattern:

US Nationwide Distribution: CA, NC, NJ and WV,

Voluntary or Mandated:

Voluntary: Firm initiated