IgM Immunoturbidimetric Assay-In vitro determination of recall
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Why was IgM Immunoturbidimetric Assay-In vitro determination of recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 05055273204001 All lots
- Product
- IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 20 kits US in total
- Distribution
- US Nationwide Distribution: CA, NC, NJ and WV,
- Recall date
- December 14, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)