IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Summary
The FDA issued a Class II for IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and by Randox Laboratories Ltd.. Reason: Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Numb.
Details
Source
Device Recall
External ID
Z-0363-2023
Action Date
2022-12-14
Status
Terminated
Category
device
Product Description
IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834
Lot/Code Info: GTIN: 05055273204001 All lots
Quantity Affected: 20 kits US in total
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
US Nationwide Distribution: CA, NC, NJ and WV,
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-01
Company
Crumlin (North), N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Randox Laboratories Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Randox Laboratories Ltd. have FDA actions?
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0363-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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