Randox Laboratories Ltd. Recall 91097
Description: IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Randox Laboratories Ltd. Recall 91097 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0363-2023 |
| Event ID | 91097 |
| Event Description | IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution: CA, NC, NJ and WV, |
| Quantity | 20 kits US in total |
| Recall 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 |
| Device Classification | 20221214 |
| Device Code Info | GTIN: 05055273204001 All lots |
| Center Classification Date | 20221202 |
| Recall Initiation Date | 20221101 |
| Recalling Firm | Randox Laboratories Ltd. |
| Initial Notification | |
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