Beckman Coulter Inc. recalls IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAG…

Recall date

July 31, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0118-2025

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

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,…

Why it was recalled

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.