FDA Medical devices recall · October 23, 2024

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent recall

Read the official FDA notice ↗

Product

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.

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410

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: Arizona California Colorado Florida Georgia Hawaii Illinois Massachusetts Michigan Missouri North Dakota New York Ohio Pennsylvania Texas

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0118-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.