Recall Z-0363-2023— Randox Laboratories Ltd.
Class II · Terminated
Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2022-11-01, terminated 2024-06-18. It names one FDA 510(k) clearance: K955797. Product: IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834. 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.
- Recalling firm
- Randox Laboratories Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-11-01
- Terminated
- 2024-06-18
- Firm location
- Crumlin (North), N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.