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  • Device 1004
  • Manufacturer 31827
  • Event 1040
  • Implant 0
Name Classification Manufacturer Risk Class Country Source
ALERE INRATIO2 PT / INR. INRatio test strips Hematology and Pathology Devices BIOSITE INCORPORATED || Importer: BIOSYSTEMS S.A (ALERE COLOMBIA S.A) Colombia INVIMA
NucliSENS® easyMAG® Magnetic Silica Hematology and Pathology Devices manufacturer #121 Colombia INVIMA
Flow Cytometer Hematology and Pathology Devices manufacturer #121 Colombia INVIMA
Cell Analysis System Hematology and Pathology Devices manufacturer #121 Colombia INVIMA
CoaguChek Hematology and Pathology Devices manufacturer #121 Colombia INVIMA
Monitoring systems Alere INRatio PT - INR Hematology and Pathology Devices Alere Portugal NADHPIP
Alere INRatio & INRatio 2 PT/INR Monitoring System Hematology and Pathology Devices Alere San Diego Inc New Zealand NZMMDSA
Alere INRatio PT/INR Monitor System Hematology and Pathology Devices Alere Medical Co Ltd New Zealand NZMMDSA
Hematoxylin II Hematology and Pathology Devices manufacturer #1479 New Zealand NZMMDSA
OptiView Amplification Kit (250 Test) Hematology and Pathology Devices manufacturer #1479 New Zealand NZMMDSA
Roche OptiView DAB IHC Detection Kit Hematology and Pathology Devices manufacturer #1479 New Zealand NZMMDSA
OptiView Amplification Kit Hematology and Pathology Devices manufacturer #1479 New Zealand NZMMDSA
Roche ultraView DAB IHC Detection Kit Hematology and Pathology Devices manufacturer #1479 New Zealand NZMMDSA
FC 500 Series Flow Cytometers Hematology and Pathology Devices Beckman Coulter Inc New Zealand NZMMDSA
alere inratio pt / inr home monitoring kit Hematology and Pathology Devices ALEREN DIEGO Italy MSHM
nuclisens easymag magnetic silica Hematology and Pathology Devices BIOMERIEUX Italy MSHM
nuclisens easymag magnetic silica; nuclisens magnetic extraction reagents Hematology and Pathology Devices BIOMERIEUX Italy MSHM
coulter epics xl ™ flow cytometer with software ii, coulter epics xl-mcl ™ flow cytometer with system ii software Hematology and Pathology Devices BECKMAN COULTER Italy MSHM
Hemostasis - PT / INRatio Hematology and Pathology Devices Alere France ANSM
Device Recall HemosIL PTFibrinogen HS PLUS Hematology and Pathology Devices Instrumentation Laboratory Co. 2 United States USFDA
Device Recall Alere INRatio PT/INR Test Strips, Alere INRatio Hematology and Pathology Devices Alere San Diego, Inc. 2 United States USFDA
Device Recall INRatio Monitors Hematology and Pathology Devices Alere San Diego, Inc. 2 United States USFDA
Device Recall INRatio 2 Monitors Hematology and Pathology Devices Alere San Diego, Inc. 2 United States USFDA
Device Recall MUM1BC5, Concentrated and Prediluted Rabbit Monoclonal antibody Hematology and Pathology Devices Biocare Medical Llc 1 United States USFDA
Device Recall PF4 Concentrated Wash Hematology and Pathology Devices Genetic Testing Institute,inc 2 United States USFDA
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Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.