This is a Class 1 recall, which is the most serious type of recall, and identifies products that can cause serious injuries or death. The FDA has advised patients to check their test strips to see if they’re involved in the recall, and if so, to talk to their doctors about getting replacements.

Chaffin Luhana’s Roche test strips lawyers are currently investigating cases in which heart disease patients used CoaguCheck test strips and later developed serious health problems.

Why Roche CoaguChek XS PT Test Strips Were Recalled

Roche initiated the CoaguChek XS PT test strip recall on September 12, 2018. They sent out an urgent medical device correction notifying doctors and medical centers about the problem—that more than 1.1 million packages of these strips, which were sent out between January 2018 and the date of the recall, could be defective.

On October 31, 2018, the company issued a press release stating that they would be proactively replacing all CoaguChek XS PT test strips in the U.S., noting that the strips were used with the following INR test meters:

• CoaguChek XS Professional
• CoaguCheck XS Pro
• CoaguChek XS Plus
• CoaguChek XS PST
• CoaguChek Vantus

The problem, according to Roche, was that in January 2018, when they recalibrated the strips to the most recent INR standard, something went wrong. Patients started to report experiencing inaccurately high INR test results. Unaware of any issues with the test strips themselves, patients could report the inaccurate measurements to their doctors, after which they could receive dose adjustments that could turn out to be dangerous.

“Patients taking warfarin who receive inaccurate INR results above their target therapeutic range,” Roche stated, “may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.” (Vitamin K helps reverse the effects of warfarin, allowing blood to clot again.)

The FDA later elevated this recall to a Class 1 recall, reflecting the most serious type of recall, noting that patients with the following conditions were at especially high risk for serious events associated with inaccurate INR measurements:

• Mechanical heart valve
• Atrial fibrillation with a high risk for stroke
• Recent thromboembolic (blood-clotting) events

According to the FDA, they received about 90 medical device reports related to this issue, including two serious patient injuries involving strokes. They are working to warn health care providers and the public about the dangers associated with this recall, and are also working with Roche to ensure that the recalled strips are removed and that patients and doctors receive the corrected strips as soon as possible.

How Roche Plans to Replace Defective INR Test Strips

Roche advised patients to stop using any CoaguChek XS PT test strips and check the lot number printed on the test strip label. Patients should then compare that number with the list of recalled lots listed below.

Lot # Location For Recalled CoaguChek Test Strips:

Recalled Lot Numbers for CoaguChek Test Strips

The company started shipping newly calibrated test strips to healthcare providers and patient self-testing service providers on October 29, 2018. Patients with recalled batches should contact their self-testing providers to find out when they will be receiving the corrected strips. They should also contact their doctors to find out how to continue monitoring their warfarin use in the meantime.

Health care providers and patients can contact Roche Diagnostics at 1-800-428-4674 for more details.

Types of Injuries Associated with CoaguCheck XS PT Test Strips

Individuals using defective CoaguChek XS PT test strips may be at risk for the following injuries:

• Blood clots
• Deep vein thrombosis
• Pulmonary embolism
• Heart attack
• Stroke
• Death

What Are CoaguChek XS PT Test Strips?

Manufactured by Roche Diagnostics, the CoaguChek XS PT test strips are designed to be used with Roche’s INR test meters to measure how a patient is responding to warfarin, the leading blood-thinning medication.

Warfarin works by reducing the ability of the blood to clot. Sold under the brand names Coumadin and Jantoven, it can reduce the risk of a heart attack, stroke, pulmonary embolism (blood clot in the lung), and other blood-clot related events. Doctors also use it to manage conditions like atrial fibrillation, deep vein thrombosis (DVT), and heart valve replacement.

There is no one-size-fits-all dosage for warfarin, because a number of different things affect how it works in the body, including the patient’s age, genetic makeup, and overall health. Patients taking warfarin, therefore, must continually monitor how it’s working to be sure that the following two conditions remain true:

1. The dose is not too high, which would increase the risk of excessive bleeding
2. The dose is not too low, which would increase the risk of a blood clot forming

To manage this monitoring, patients use devices called INR test meters.

What Are INR Test Meters?

INR test meters are portable, battery-operated devices that patients use to make sure their warfarin is working as it should. The meters are used with test strips like the CoaguChek XS PT test strips to measure how long it takes blood to clot. A shorter period of time (smaller INR number) means the blood may be clotting too quickly, whereas a longer period of time (larger INR number) may indicate a risk of excessive bleeding.

INR test meters allow patients to monitor their results at home and at the doctor’s office, providing a more convenient and consistent approach to care.

To use the device, the patient inserts the test strip into the meter, then pricks a finger and applies the blood to the other end of the test strip. The meter “reads” the test strip, measuring how long it takes the blood to clot, and then shows the results on the screen in the form of the “International Normalized Ratio (INR).”

The INR was devised in the 1980s, and provides a standardized method of reporting the effects of blood thinning drugs like warfarin. Doctors set an INR target range for each patient, which usually sits somewhere between 2.0 and 3.0, though the range can vary depending on the patient’s needs and condition.

Roche CoaguChek XS PT Test Strip Lawsuits

Though Roche was the one to detect the issue with their test strips, they allowed the strips to be sold and used by thousands of patients for eight months before they took action. That means thousands of patients were put at risk while using a product they believed was reliable.

If you or a loved one used a Roche CoaguChek XS PT test strip and received a faulty reading that led to a serious injury, you may be eligible to file a CoaguChek XS PT test strip lawsuit to recover damages. Chaffin Luhana is now investigating these cases, and will work to help you receive the compensation you deserve. Contact us today for a free case review.