Randox Laboratories Ltd.: IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832

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

Details from the source

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 Distribution: US Nationwide Distribution: CA, NC, NJ and WV, Quantity: 20 kits US in total Lot/code info: GTIN: 05055273203882 All lots

UPC codes

05055273203882

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.