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Name Classification Manufacturer Risk Class Country Source
Device Recall 1500T12 Cool Path Ablation System Generator St Jude Medical United States USFDA
Device Recall 1500T14 Cardiac Ablation System Generator St Jude Medical United States USFDA
Device Recall 1500T14 Cardiac Ablation System Remote Control St Jude Medical United States USFDA
Device Recall Alere Cholestech LDX Multianalyte Controls Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 1 United States USFDA
Device Recall Abbott Laboratories, Inc., ARCHITECT Estradiol assay Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories 1 United States USFDA
Device Recall ARCHITECT c4000 Cuvette Segment Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Device Recall ARCHITECT c4000 Cuvette Segment Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Device Recall ARCHITECT c8000 Cuvette Segment Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Device Recall ARCHITECT c16000 Cuvette Segment Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Device Recall ARCHITECT DHEAS Reagent Clinical Chemistry and Clinical Toxicology Devices Abbott Gmbh & Co. KG 1 United States USFDA
Phosphorus Reagent Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Quality Control Material Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 1 United States USFDA
Device Recall Architect Alkaline Wash Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories 1 United States USFDA
Abbott Laboratories HbA1c Calibrators Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories 1 United States USFDA
Alere Cholestech LDX Analyzer and Alere Cholestech Lipid Profile Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 1 United States USFDA
ARCHITECT SHBG Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories 1 United States USFDA
ARCHITECT Instrument Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Peristaltic Head Tubing Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Inverness Medical BioStar Strep A OIA MAX Immunology and Microbiology Devices Binax, Inc. dba IMPD 1 United States USFDA
ARCHITECT i System Assay CD ROM Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories 1 United States USFDA
Electronic Data Interchange Clinical Chemistry and Clinical Toxicology Devices Abbott Point of Care Inc. 1 United States USFDA
iSTAT Level 2 Control Clinical Chemistry and Clinical Toxicology Devices Abbott Point of Care Inc. 1 United States USFDA
Lipase Reagent Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories, Inc 1 United States USFDA
Device Recall Architect c8000 Clinical Chemistry and Clinical Toxicology Devices Abbott Laboratories 1 United States USFDA
Device Recall ACON Mission Breath Alcohol Detector Clinical Chemistry and Clinical Toxicology Devices Acon Laboratories, Inc. 1 United States USFDA