IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834

FDA device recall Z-0363-2023 · posted 2022-12-03 · Terminated

Recall details

Recalling firm

Randox Laboratories Ltd.

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

Action taken

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

Root cause

Under Investigation by firm

Status

Terminated

Product code

DFT

Quantity affected

20 kits US in total

Distribution

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

Date initiated

2022-11-01

Date posted

2022-12-03

Date terminated

2024-06-18

Location

Crumlin, North, Ireland

Related 510(k) clearances