# FDA recall Z-0362-2023

> **Randox Laboratories Ltd.** · Class II · device recall initiated 2022-11-01.

## Product

IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma  Catalog Number: IA3832

## 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

## Distribution

US Nationwide Distribution: CA, NC, NJ and WV,

## Key facts

- **Recall number:** Z-0362-2023
- **Recalling firm:** Randox Laboratories Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-11-01
- **Report date:** 2022-12-14
- **Termination date:** 2024-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Crumlin (North), N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0362-2023

## Citation

> AI Analytics. FDA recall Z-0362-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0362-2023. Source: US FDA. Licensed CC0.

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