FDA (Devices) recall action 91097
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Randox Laboratories recalls IgM and IgA immunoturbidimetric assay kits due to carryover contamination that can cause elevated test results when run immediately after Fructosamine tests on RX instruments.
Randox Laboratories updated its carryover avoidance protocol for IgA and IgM immunoturbidimetric assays. Running these assays immediately after Fructosamine tests on RX instruments can cause falsely elevated results (up to +13% for IgA, +51% for IgM).