HemoSense INRatio Test Meter found defective, FDA demands action

By Angela McDaniels

Seattle, Oct. 13 - An inspection by the U.S. Food and Drug Administration has found that biotech HemoSense, Inc. knew its INRatio Test Meters were generating significantly erroneous readings, but failed to report this finding.

INRatio meters are used to monitor blood coagulation and adjust anticoagulant medication doses, and consumers have filed several complaints about the device with the FDA, including an incident in which an inaccurate INRatio reading resulted in patient hospitalization.

HemoSense was told to take corrective action, but in a warning letter included in a recent 8-K filing with the Securities and Exchange Commission, the FDA describes HemoSense's response as inadequate, as the company did not provide "sufficient detail and documentation" of its preventive actions.

HemoSense was reminded that "federal agencies are advised of the issuance of all warning letters about devices so that they may take this information into account when considering the award of contracts."

The FDA went on to say that should HemoSense fail to address the situation promptly, the agency may take regulatory action including "seizure, injunction, and/or civil money penalties."

HemoSense has submitted a further written response to the FDA, though the company maintains in the SEC filling that its initial response to the FDA warning letter was adequate.

HemoSense is based in San Jose, Calif., and develops, manufactures and sells handheld blood coagulation monitoring systems.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.