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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
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