Concerned over nine serious adverse events, three of which described bleeding associated with patient deaths, Alere Inc. of Waltham, MA issued a voluntary urgent recall of its PN 99008G2 INRatio2 ...
Patients taking the oral anticoagulant drug warfarin (Coumadin) or being given heparin injections and their in-office and home healthcare teams should check the brand of their PT/INR test strips and ...
Terrific Care/Medex Supply had purchased these test strips (which were distributed by Roche Diagnostics outside the country) from an unknown source, imported and sold them in the US. The Food and Drug ...
Alere has issued a voluntary correction to users of the Alere INRatio and INRatio 2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor ...
The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips ...
In reaction to three patient deaths associated with its INRatio2 PT/INR Professional Test Strips, Alere ($ALR) initiated a voluntary Class I recall of the products ...
A concerned daughter brings her father to a hospital as her father noticed blood in his stools. He also had large bleeding patches on the back of the chest and thighs. She recalls that her father is ...
A new recall has been issued CoaguChek XS PT test strips, used to monitor international normalized ratio (INR) in patients taking warfarin, due to inaccurately high readings. Roche Diagnostics ...
Evidence that Theranos may have returned potentially faulty results to patients have been documented in a government investigation, the Wall Street Journal reports. Citing people familiar with the ...