IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
FDA Recall Z-0363-2023 · Posted 2022-12-03
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Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeDFT
Date Initiated2022-11-01
Date Terminated2024-06-18
Product Quantity20 kits US in total
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
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 [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
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution: CA, NC, NJ and WV,
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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