Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM Recalled by Beckman Coulter Inc. Due to Firm identified two lots of reagents that are...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.
Affected Products
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.
Quantity: 12,102 reagents
Why Was This Recalled?
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
Where Was This Sold?
This product was distributed to 15 states: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, NY, ND, OH, PA, TX
About Beckman Coulter Inc.
Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report