Z-0363-2023 Class II Terminated
FDA device recall Z-0363-2023 was initiated by Randox Laboratories Ltd. on Nov 1, 2022 and is designated Class II. 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… The recall status is terminated (terminated Jun 18, 2024). Affected quantity: 20 kits US in total.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2022
- Initiation Date
- Nov 1, 2022
- Termination Date
- Jun 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 kits US in total
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
Distribution Pattern
US Nationwide Distribution: CA, NC, NJ and WV,
Code Information
GTIN: 05055273204001 All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0363-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026