IgA and IgM Immunoturbidimetric Assay Testing Order Carryover Avoidance Update
Randox Laboratories updated its carryover avoidance protocol for IgA and IgM immunoturbidimetric assays. Running these assays immediately after Fructosamine tests on RX instruments can cause falsely elevated results (up to +13% for IgA, +51% for IgM).
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported adverse events or patient harm. The hazard is procedural (testing-order interference), not a product defect. The source text indicates the risk is theoretical ('can lead to'), matching the rubric criterion for 'voluntary precautionary recalls' without reported injuries.
Plain-English summary
Randox Laboratories Ltd. has updated its carryover avoidance technical bulletin for the IgA Immunoturbidimetric Assay (Catalog Number IA3832). The update addresses a testing-order protocol issue affecting IgA and IgM immunoturbidimetric assays performed on RX instruments.
When IgA and IgM assays are run immediately after Fructosamine assays (Catalog Numbers FR3133 or FR4030) on the same instrument, carryover contamination can occur. This can elevate both Quality Control and patient test results by up to 13% for IgA and 51% for IgM, potentially resulting in falsely elevated immunoglobulin measurements that may delay sample processing or produce erroneous clinical results.
Approximately 20 kits were distributed in the United States to locations in California, North Carolina, New Jersey, and West Virginia. Laboratory directors and healthcare providers should implement the updated carryover avoidance protocol by ensuring that IgA and IgM assays are not run immediately after Fructosamine assays on RX instruments. Contact Randox Laboratories for the updated technical bulletin and implementation guidance.
The recalled product
- Product
- IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
- Manufacturer
- Randox Laboratories Ltd.
- Affected units
- 20
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: 05055273203882 All lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Randox Laboratories Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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