FDA Medical Device Recalls (openFDA)
Randox Laboratories Ltd.: IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
- Recall number
- Z-0363-2023
- Recalling firm
- Randox Laboratories Ltd.
- Product
- IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
- Status
- Terminated
- Initiated
- 2022-11-01
- Posted
- 2022-12-03
- Terminated
- 2024-06-18
- 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
- Root cause
- Under Investigation by firm
- Action
- 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 technical.services@randox.com 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
- Quantity
- 20 kits US in total
- Distribution
- US Nationwide Distribution: CA, NC, NJ and WV,
- Lot, serial or model codes
- GTIN: 05055273204001 All lots
- 510(k) numbers
- ["K955797"]
- PMA numbers
- not on file
- Product code
- DFT
- Firm FEI
- 1000361607
- Firm city
- Crumlin
- Firm state
- North
- Firm country
- Ireland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28