IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
Reported: December 14, 2022 Initiated: November 1, 2022 #Z-0362-2023
Product Description
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
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
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 20 kits US in total
- Distribution
- US Nationwide Distribution: CA, NC, NJ and WV,
- Location
- Crumlin (North), N/A
Frequently Asked Questions
What product was recalled? ▼
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832. Recalled by Randox Laboratories Ltd.. Units affected: 20 kits US in total.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 14, 2022. Severity: Moderate. Recall number: Z-0362-2023.
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