Lower riskMedical device recall · FDA · Published November 1, 2022
Randox IgM Assay Recall: Risk of inaccurate test results
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. Read more at govinfonow.com/recall/59785-randox-igm-assay-recall-risk-of-inaccurate-test-results.
“Randox IgM Assay Recall: Risk of inaccurate test results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59785-randox-igm-assay-recall-risk-of-inaccurate-test-results. Based on FDA recall #Z-0363-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2023%22&limit=1).
Randox Laboratories Ltd. recalled IgM Immunoturbidimetric Assay (Catalog Number IM3834) due to potential erroneous elevated test results, the FDA said on Nov. 1, 2022. The recall affects all lots distributed nationwide.
How to tell if you have it
Brand: Randox
Product: IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma
Catalog Number: IM3834
UPC: 05055273204001
Distribution: US Nationwide (CA, NC, NJ, WV)
Quantity: 20 kits
The hazard
The recall updates a technical bulletin stating that IgA and IgM assays should not be run immediately after Fructosamine assays on RX instruments. This can cause an elevation in Quality Control and Patient results of up to +13% for IgA and +51% for IgM, potentially leading to delayed patient samples or erroneous elevated test results.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a June 7, 2024 Cystatin C Reagent recall for missing FDA 510(k) and an April 5, 2024 Evidence MultiSTAT Software recall for light leak risk. Other recent recalls of similar products include the Nov. 21, 2025 Roche Elecsys Anti-TSHR Assay Recall, the June 12, 2026 Tosoh ST AIA-Pack Testosterone Recall, and the July 13, 2026 Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall.
How to tell if you have this one
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.
Brand
Randox
Product
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide Distribution: CA, NC, NJ and WV,
Recall number
Product, codes & lots
Z-0362-2023
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832; GTIN: 05055273203882 All lots
Z-0363-2023
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834; GTIN: 05055273204001 All lots
Based on the official FDA remedy
What to do — step by step
Review Test Sequence
Ensure IgM tests are not run immediately after fructosamine tests (FR3133 or FR4030) to avoid inaccurate results.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution: CA, NC, NJ and WV,” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, New Jersey, North Carolina, West Virginia.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0363-2023 (November 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0363-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.