Hemosense, Inc.
FDA adverse event reports naming Hemosense, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: HEMOSENSE, INC..
- Total reports
- 1,762
- Deaths
- 5
- Injuries
- 166
- Malfunctions
- 1,552
Reports per year
Source: FDA adverse event reports by year received, 2004–2009. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Multipurpose For In Vitro Coagulation StudiesJPA1,521
- Test, Time, ProthrombinGJS144
- Test, FibrinogenGIS66
- Instrument, Coagulation, AutomatedGKP23
- Product code ------4
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS2
- Laparoscope, General & Plastic SurgeryGCJ1
- System, X-Ray, Fluoroscopic, Image-IntensifiedJAA1
Recent recalls
- 2012-04-20TerminatedNonconforming Material/Component
Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.
- 2009-05-22TerminatedNonconforming Material/Component
HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
INRatio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.
- 2005-11-15TerminatedOther
HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134
A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.
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