Devices

Name Classification Manufacturer Risk Class Country Source
Device Recall IMO402 Mononucleosis Rapid Test Device Immunology and Microbiology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Cholestech LDX hsCRP Test Cassette, Immunology and Microbiology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Cholestech LDX ALT AST Test Cassette Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 1 United States
Device Recall Triage TOX Drug Screen Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Triage TOX Drug Screen 9 Panel Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Triage ToxMTD Drug Screen Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Device Recall Triage Ddimer PN 98100 Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Triage BNP PN 98000XR Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Triage Profiler SOB Panel PN 97300 Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Triage Cardiac Panel PN 97000HS Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere Triage CardioProfiler Panel PN 97100CP Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Alere Cholestech LDX Analyzer and Alere Cholestech Lipid Profile Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 1 United States
INRatio/INRatio2 Test Strips Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Quality Control Material Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 1 United States
Alere hCG Combo Cassette (20/10 mIU/mL) KIt Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Device Recall Triage Drugs of Abuse Plus TCA 25 Test Kit Clinical Chemistry and Clinical Toxicology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere INRatio/ INRatio2 PT/INR Test Strips Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall INRatio PT/INR Test Strips Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall INRatio2 PT/INR Professional Monitoring System Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere INRatio2 Replacement Monitor (Home) Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall INRatio2 PT/INR Home Monitoring System Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall INRatio2 PT/INR Professional Testing System Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere INRatio Replacement Monitor Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall INRatio Prothrombin Time (PT) Monitoring System Hematology and Pathology Devices Alere San Diego, Inc. 2 United States
Device Recall Alere INRatio2 PT/INR Professional Monitoring System Hematology and Pathology Devices Alere San Diego, Inc. 2 United States