Test Strips Recalled for Inaccurate INR Results in Patients Taking Warfarin
The Kansas City product liability attorneys at Goza & Honnold are handling cases involving injuries from CoaguChek XS PT Test Strips. The test strips, manufactured by Roche Diagnostics, were recalled in 2018 and still sold by another distributor in the United States for several months. After Roche recalibrated CoaguChek XS PT Test Strips, patients who used these strips for INR testing received inaccurate results, exposing them to potentially life-threatening injuries.
What are CoaguChek Test Strips?
CoaguChek is a brand of test strip that is used in conjunction with a test meter to monitor patients’ responses to the anticoagulant warfarin (also manufactured under the brand names Jantoven and Coumadin). The test meter provides a reading for the amount of time it takes for a patient’s blood to clot, based on the International Normalized Ratio (INR).
Doctors prescribing warfarin to patients will use INR test results to adjust or maintain patients’ doses of the drug. If a patient’s INR reading is low, a doctor might increase the dose of warfarin. If the INR reading is high, a doctor might decrease or discontinue the patient’s warfarin. A correct INR reading, therefore, is crucial to achieving optimal therapeutic benefit of the drug.
Potential Injuries from Inaccurate INR Test Results
If a patient’s INR test results are inaccurate, a doctor might erroneously adjust the patient’s warfarin to an inappropriate amount. In the case of CoaguChek XS PT Test Strips, patients’ INR readings were falsely elevated, which caused some patients’ doctors to lower their warfarin dose or stop their warfarin prescriptions.
A dose of warfarin that is too low exposes patients to the medical risks the drug is intended to address. Injuries from adjusted dosing due to inaccurately high INR readings can include:
- Blood clots
- Deep vein thrombosis (DVT)
- Pulmonary embolism
Roche CoaguChek XS PT Test Strips Recalled
In November 2018, the U.S. Food and Drug Administration announced a Class I recall of CoaguChek XS PT Test Strips due to the potential for the inaccurate readings to lead to serious patient injuries and death. A Class I recall is the most serious recall classification by the FDA. At the time of the recall, the FDA was aware of 90 incidents involving inaccurate INR tests with CoaguChek test strips, including two reports of stroke resulting in serious injuries.
Roche Diagnostics indicated that the issue with the test strips began when the company recalibrated them to conform to the new INR International Standard in January 2018. An error in the recalibration process caused the strips to produce results higher than a patient’s actual INR. The recall applied to CoaguChek test strips distributed in the United States from January 2018 to October 2018 for use by patients at home and by doctors and medical personnel in-office. More than 1 million units were included in the recall.
Continued Sale of CoaguChek Test Strips by Terrific Care/Medex Supply
In February 2019, the FDA announced a second recall of CoaguChek XS PT test strips. The strips included in this recall were also manufactured by Roche but were not labeled for or authorized for sale inside of the United States. According to the FDA, distributor Terrific Care/Medex Supply had been buying and importing the strips to the U.S., then distributing them for months after the initial recall.
As with the original recall, the FDA advised patients and health care providers to immediately stop using the CoaguChek test strips and use other devices for testing INR. All patients who were taking warfarin were potentially at risk for injury from the defective CoaguChek test strips. This includes millions of Americans exposed not only from Roche’s sale of the test strips throughout most of 2018 but also from continued sale after the recall began.
Contact Goza & Honnold, LLC
If you or a loved one experienced an injury related to inaccurate results from CoaguChek test strips, contact Goza & Honnold today at (913) 451-3433 to speak to one of our attorneys. We offer confidential consultations at no cost to you and will help you understand whether you are eligible to file a lawsuit.