FDA Device recall Z-0363-2023
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
- FDA Device
- Class II
- terminated
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834 by Randox Laboratories, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0363-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-11-01 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Randox Laboratories |
| Distribution | US |
Product
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Reason
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
Identifiers
| code_info | GTIN: 05055273204001 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0363-2023%22
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