Randox recalls IgA and IgM blood test kits (IA3832) due to potential inaccurate results if used immediately after specific fructosamine tests. All lots affected.
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 recalls IgA and IgM blood test kits (IA3832) because using them right after certain fructosamine tests can cause test results to be too high, possibly delaying patient care or causing errors.
The test kits can produce inaccurate results if run immediately after specific fructosamine tests (FR3133 or FR4030). This causes test results to be up to 13% higher for IgA and 51% higher for IgM, which might delay patient care or give false high readings.
Lab technicians and healthcare providers using Randox IgA/IgM test kits (IA3832) with specific fructosamine tests. Those most at risk are labs that run these tests without proper timing between assays.
Check for the catalog number IA3832 on the test kit. All lots are affected. The test kits are used for in vitro determination of IgA and IgM in blood samples.
Ensure at least a specific time gap between running IgA/IgM tests and fructosamine tests to avoid inaccurate results.
The test kit (IA3832) can cause inaccurate results if used immediately after certain fructosamine tests, leading to potentially higher test values for IgA and IgM.
Look for the catalog number IA3832 on the test kit. All lots are affected.
Ensure at least a specific time gap between running IgA/IgM tests and fructosamine tests to avoid inaccurate results.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0362-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-0362-2023 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.
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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.
