Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

Potential loose cable connections on the reagent cooler, which could result in temperature errors and eventual reagent cooler failure. Could cause burn and shock injuries to users and a delay in test results. Device design has mitigated this risk, but it is a possibility.

Abbott notified customers on about 04/05/2019 via "Product Correction Urgent - Immediate Action Required" letter. The letter instructed customers to power off their Alinity i System if they experience unexpected reagent supply temperature errors, detect a burning smell or visible smoke. They were also instructed that their Abbott representative will contact them to schedule the replacement of the impacted parts, to forward the Product Correction letter if the device has been further distributed, retain the letter for laboratory records, and complete and return the attached Customer Reply form. Questions can be directed to Customer Service at at 18774ABBOTT (available 24 hours a day, 7 days a week) for US customers. For customers outside the US, they are instructed to contact their local area Customer Service.