Recall Z-0362-2023 ยท CZP Iga, Antigen, Antiserum, Control
Randox Laboratories Ltd.
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
| Date | Dec 3, 2022 (initiated Nov 1, 2022) |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Randox Laboratories extended recall notification to the US Distribution center on 11/01/22 via email. The US distributor contacted customers on 11/1/22 via email . Letter states reason for recall, health risk and action to take: Review your instrument testing order in line with the Carryover Avoidance Technical Bulletin (RXTB-0136} " Update the RX user manual with the updated Carryover Avoidance Technical Bulletin (RXTB-0136} and ensure all operators are aware of the recommendations. Discuss the contents of this notice with your Medical Director. " Complete and return the response form 1218 |
| Quantity | 20 kits US in total |
| Distribution | US Nationwide Distribution: CA, NC, NJ and WV, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955794 | IGA IMMUNOTURBIDIMETRIC & CALIBRATOR Randox Laboratories, Ltd., Apr 5, 1996 |