IgM and IgA Assay Kits Recalled for Test Carryover Risk
Randox Laboratories recalls IgM and IgA immunoturbidimetric assay kits due to carryover contamination that can cause elevated test results when run immediately after Fructosamine tests on RX instruments.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic medical device with theoretical risk of erroneous test results from carryover contamination. Meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported,' as no illnesses or injuries have been documented in the source.
Plain-English summary
Randox Laboratories is recalling IgM and IgA immunoturbidimetric assay kits (Catalog Number IM3834) following a technical bulletin update regarding a carryover contamination issue.
When IgA and IgM assays are run immediately after Fructosamine tests (Catalog Numbers FR3133 or FR4030) on the same RX instruments, carryover contamination can occur. This contamination can elevate Quality Control and patient test results by up to 13% for IgA and up to 51% for IgM, potentially resulting in erroneous elevated test results that may delay patient sample processing or lead to inaccurate diagnoses.
Approximately 20 kits were distributed in the United States to healthcare facilities in California, North Carolina, New Jersey, and West Virginia.
Healthcare providers should not run IgA and IgM assays immediately after Fructosamine tests on the same RX instrument. By observing this testing order restriction, facilities can prevent the carryover issue and ensure accurate patient results.
The recalled product
- Product
- IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- erroneous-test-results
- carryover-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 05055273204001 All lots
Distribution
Distributed nationwide across the United States.
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