Beckman Coulter Inc.: 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

Hazard

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

Details from the source

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, Quantity: 12,102 reagents Lot/code info: Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410

UPC codes

15099590221195

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.