FDA Enforcement
Class II
Terminated
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Recall: Z-0363-2023
·
Reported December 14, 2022
Enforcement
- Recall Number
- Z-0363-2023
- Event ID
- 91097
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Randox Laboratories Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- December 14, 2022
- Initiation Date
- November 1, 2022
- Classification Date
- December 2, 2022
- Termination Date
- June 18, 2024
- Address
- 55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland
Description
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
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
Code Info
GTIN: 05055273204001 All lots
Distribution
US Nationwide Distribution: CA, NC, NJ and WV,
Quantity
20 kits US in total