IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMM
Summary
The FDA issued a Class II for IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM re by Beckman Coulter Inc.. Reason: Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU.
Details
Source
Device Recall
External ID
Z-0118-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
Lot/Code Info: Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410
Quantity Affected: 12,102 reagents
Reason for Recall
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Distribution
U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan Province of China, and Turkey,
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-31
Company
Brea, CA
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 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 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 (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0118-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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