Business Insider

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

SILVER SPRING, Md., Feb. 1, 2019 /PRNewswire/ -- 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 ...
Monthly Prescribing Reference

FDA: Class I Recall of Test Strips Due to Inaccurate INR Results

Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled. Roche Diagnostics has issued a recall of certain lots of CoaguChek XS PT Test Strips, ...
TCTMD

More INR Test Strips Recalled Due to Inaccurately High Results

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 ...
TCTMD

INR Test Strips Recalled Due to Inaccurate Measurements

Roche Diagnostics has recalled more than 1.1 million packages of its CoaguChek XS PT test strips, which are used for monitoring international normalized ratio (INR) in patients taking warfarin. The US ...
Medscape

Distributor Recalls All Its Roche CoaguChek Anticoagulation Test Strips

Terrific Care/Medex Supply has announced a recall of all test strips made by Roche Diagnostics for use with its CoaguChek warfarin anticoagulation meters that it has distributed for direct consumer ...
Medscape

FDA: Class I Recall of Roche Warfarin Test Strips for INR Monitoring

A voluntary recall of certain test strips made by Roche Diagnostics for use with its CoaguChek warfarin anticoagulation meters is now categorized as Class I, the US Food and Drug Administration has ...
Reuters

Roche says resolves CoaguChek reliability issue

ZURICH, May 23 (Reuters) - Swiss drugmaker Roche Holding AG said on Wednesday it had resolved a reliability concern over its CoaguChek anticoagulation monitoring test strips in the United States.
News Medical

Certain test strips used with home-use devices may provide inaccurate results, warns FDA

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 ...
UPI

FDA recalls test strips over inaccurate warfarin test results

Nov. 2 (UPI) --The U.S. Food and Drug Administration has recalled test strips for levels of the blood thinner warfarin because they may provide inaccurate results. The federal agency said in an ...
National Institute for Health and Care Excellence

Atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system)

The CoaguChek XS system (Roche Diagnostics) comprises a meter and specifically designed test strips that can analyse a blood sample (fresh capillary blood or fresh untreated whole venous blood) and ...
News Medical

FDA warns that some home-use test strips may provide inaccurate results

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 ...