IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM… — Class II medical device recall Z-0363-2023
Terminated recall by Randox Laboratories Ltd., reported 2022-12-14, distributed nationwide. Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immed
| Recall number | Z-0363-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2022-11-01 |
| Classified | 2022-12-02 |
| Reported by FDA | 2022-12-14 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 20 kits |
| UPC / GTIN / UDI-DI | 05055273204001 |
| Model numbers | IM3834 |
Product
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0363-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.