Roche To Replace All Warfarin CoaguChek Test Strips In The U.S.

Following a recall earlier this month for more than one million anticoagulant test strips, due to a risk that they may provide inaccurate readings, the manufacturer indicates that newly calibrated replacement strips are now available for patients to use with the Roche INR Test Meters. 

The U.S. Food and Drug Administration (FDA) announced the CoaguChek XS PT test strip replacements are now available, meeting the International Normalized Ratio (INR) Standard to prevent the possibility of inaccurate blood coagulation readings and possible over- or under-dosing risks.

Earlier this month, the 1.1 million CoaguChek XS PT Test strips were recalled following 90 reports of the test strips failing to give accurate blood thinner dosing recommendations. Of the reported problems, at least two patients suffered strokes from inaccurate dosing instructions.

CoaguChek XS PT Test strips are used with the Roche INR Test Meters to monitor a patient’s response to anticoagulants, such as Warfarin, Coumadin and Jantoven, which are prescription blood thinners used by individuals at risk of suffering a blood clot in veins or arteries. These conditions leave patients vulnerable to strokes, heart attacks or other serious conditions if not properly treated.

The CoaguChek test strips are designed be inserted into the meter where a lance needle pricks the user’s skin to apply blood to the test strip. The Roche INR Test Meters then calculates how long it takes for the blood to clot and determines the proper dosage of anticoagulant for physicians to prescribe.

During the recall investigation, manufacturing company Roche Diagnostics warned the CoaguChek strips were not updated to meet the INR standards for which the Roche Test Meters is programmed to calculate blood coagulation. This conflict in standards could result in inaccurate blood thinner dosage recommendations.

Patients who suffer from a blood thinner medication error could experience blood clots, severe bleeding, red or brown urine, black or bloody stool, severe headache and stomach pain, joint pain, vomiting, coughing up blood, dizziness, easily bruising, internal bleeding, heart attack, or strokes that could be fatal. The FDA warned patients with mechanical heart valves, atrial fibrillation and recent thromboembolic events are at an increased risk and should consult with their physicians immediately.

Roche is asking patients and healthcare providers to discard any CoaguChek XS PT Test Strips included in the original recall. Patients and healthcare providers may verify whether a test strip is included in the recall by checking the products lot number printed on the test strip label.

Roche has begun shipping the newly calibrated test strips to healthcare providers and patient self-testing service providers across the nation. Healthcare providers and patients with additional questions or concerns are encouraged to contact Roche Diagnostics Point of Care Technical Service at 1-800-428-4674.