Randox recalls IgM Immunoturbidimetric Assay (Catalog IM3834) due to potential inaccurate test results from improper use with specific fructosamine tests.
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
Rando: Randox is recalling its IgM Immunoturbidimetric Assay (Catalog IM3834) because running it immediately after certain fructosamine tests can cause test results to be up to 51% higher than they should be. This may lead to delayed patient care or incorrect diagnoses.
The assay can produce inaccurate results if run immediately after specific fructosamine tests (FR3133 or FR4030). This causes test results to be too high by up to 51% for IgM, potentially delaying patient care or causing incorrect diagnoses.
Healthcare professionals using Randox IgM tests for blood analysis. Those most at risk are labs that run tests without following the correct sequence with fructosamine tests.
Check for the catalog number IM3834 on the test kit. All lots are affected. The product is used in blood testing for IgA and IgM levels.
Ensure IgM tests are not run immediately after fructosamine tests (FR3133 or FR4030) to avoid inaccurate results.
Running the IgM assay immediately after specific fructosamine tests can cause test results to be up to 51% higher for IgM, leading to potential delays in patient care or incorrect diagnoses.
The recalled product is the IgM Immunoturbidimetric Assay with catalog number IM3834. All lots are affected.
You should review your test sequence to ensure IgM tests are not run immediately after fructosamine tests (FR3133 or FR4030).
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0363-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-0363-2023 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
