Recalls for Reagent, Borrelia Serological Reagent

5 on file

GET TESTED INTERNATIONAL AB
Open, ClassifiedDec 1, 2025
Distribution without premarket approval/clearance.
Innominata Dba Genbio
TerminatedMar 8, 2013
Multiple incidents of low-reacting assay plates.
Biomerieux, Inc.
TerminatedJul 20, 2004
Kit may contain incorrect components
bioMerieux, Inc.
Open, ClassifiedUnknown
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
bioMerieux, Inc.
Open, ClassifiedUnknown
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.