medical Class II Updated 2019-06-05

Abbott Gmbh & Co. KG recalls Alinity i Processing Module, 03R65 01, with the below compon

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: 03R65 01, all Serial Numbers; a. TED (Thermo Electric Device) Engine, Reagent cooler - Part Numbers A 30103732 01, A 30103732 02 with all Serial Numbers; b. CABLE, POWER OUT, TED CNTRLER - Part Numbers A 35006203 01, A 35006203 02 with all Serial Numbers
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →