IgA Immunoturbidimetric Assay- In vitro determination of… recallZ-0362-2023 · Randox Laboratories Ltd. · initiated Nov 1, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Under Investigation by firm
What the company is doing
Randox Laboratories extended recall notification to the US Distribution center on 11/01/22 via email. The US distributor contacted customers on 11/1/22 via email . Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0136} " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0136} and ensure all operators are aware of the recommendations. Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organisation. If you have any questions or concerns, please contact Randox Technical Services
Recall details
- Recall number
- Z-0362-2023
- Status
- Terminated
- Initiated by the company
- Nov 1, 2022
- Posted by the FDA
- Dec 3, 2022
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 20 kits US in total
- Product code
- CZP
- FDA submissions
- K955794
- Distribution
- US Nationwide Distribution: CA, NC, NJ and WV,
Product description
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
Code information (models, lots, serial numbers)
GTIN: 05055273203882 All lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IgA IA3832Randox Laboratories Limited · Iga, Antigen, Antiserum, Control1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91097).
- Z-0363-2023 · TerminatedIgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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