FDA-Device2022-12-14Class II
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Randox Laboratories Ltd.
Hazard
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
Sold states
US Nationwide Distribution: CA, NC, NJ and WV,
Affected count
20 kits US in total
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0363-2023Don't want to check this manually?
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