Medical Device Recall: 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 d
Beckman Coulter Inc. · July 31, 2024
Reason for Recall
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
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.
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,
States Affected
AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, TX
Quantity Affected
12,102 reagents
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0118-2025
Status: ongoing
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