Device product
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Z-0363-2023
Product summary
- Event
- Event 91097
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 kits US in total
- Official record key
device-enforcement:Z-0363-2023
Official wording
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 information: GTIN: 05055273204001 All lots
Distribution pattern: US Nationwide Distribution: CA, NC, NJ and WV,
Derived failure modes
-
Unknown
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