Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results
The FDA has identified this as a Class I recall, the most serious type of recall. The use of these devices may cause serious injuries or death.
- Recalled Product(s): CoaguChek XS PT Test Strips purchased from Terrific Care, LLC. or Medex Supply
- Lot Numbers: All lot numbers sold by Terrific Care LLC. or Medex Supply
- Manufacturing Dates: October 2017 to May 2018
- Distribution Dates: December 27, 2017, to December 15, 2018
- Devices Recalled in the U.S.: 759 boxes
Device Use
The CoaguChek XS PT Test Strips, manufactured by Roche Diagnostics, is used with the CoaguChek XS System to monitor patient response to warfarin (also known by the brand names Coumadin and Jantoven), a blood thinner prescribed to prevent and treat blood clots. The test strip is inserted into the CoaguChek XS System, and then a medical pricking needle (a lancet) is used to obtain blood from the patient’s finger (capillary) which is applied to the test strip. The meter reads the test strip, measures how long it takes the blood to clot and provides the result based on a standardized calculation in the form of the International Normalized Ratio, or INR. Patients and physicians use the INR to determine if warfarin dosing is appropriate.
Reason for Recall
Terrific Care, LLC. / Medex Supply is recalling the Roche Diagnostics CoaguChek XS PT Test Strips due to inaccurate INR test results when compared to laboratory results. The test strips may provide results that are higher than the actual INR. Because of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots. Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat) who are at an elevated risk of stroke, or those who had a recent blood clot.
This recall is related to Roche Diagnostics’ recent U.S. recall of its CoaguChek XS PT Test Strips. However, the CoaguChek XS PT Test Strips distributed by Terrific Care LLC. /Medex Supply include catalog/REF numbers that were not included in the recent Roche recall because the test strips were not labeled or authorized for sale in the United States and were only distributed by Roche Diagnostics outside the U.S. Terrific Care, LLC. / Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the United States.
Use of recalled test strips may increase the risk of serious adverse health consequences, including, stroke, irreversible brain damage, and death.
Who is affected?
- Patients that bought Roche CoaguChek XS PT Test Strips from Terrific Care, LLC. / Medex Supply.
- Patients with the following conditions are at especially high risk for serious events associated with inaccurate INR measurements:
- Mechanical heart valve
- Atrial fibrillation and high-risk CHA2DS2-VASc scores
- Recent thromboembolic events
- Patients with the following conditions are at especially high risk for serious events associated with inaccurate INR measurements:
- Health care providers, pharmacies, and health care facilities that purchased CoaguChek XS PT Test Strips from Terrific Care, LLC. / Medex Supply
- Distributors that purchased CoaguChek XS PT Test Strips from Terrific Care, LLC. / Medex Supply
What to Do
On January 28, 2019, Terrific Care, LLC sent an Urgent Medical Device Recall Notification letter to customers. The letter asked customers to:
- Switch to new batches of CoaguChek XS PT Test Strips that are not affected by the recall. New batches of CoaguChek XS PT Test Strips may be obtained by contacting Roche Diagnostics Corporation at 1-800-428-4674.
- Patients should contact their health care provider to determine an alternative testing method while waiting for replacement CoaguChek XS PT Test Strips that are not affected.
- Immediately stop using all CoaguChek XS Test Strips purchased directly from Terrific Care, LLC. and Medex Supply.
- If you have a product to return, send an email to RMA@medexsupply.com or call a customer service specialist at 888-433-2300 between the hours of 9:00 am - 5:00 pm Eastern Standard Time, Monday – Thursday.
- Include the “order ID” and insert “Recall” in the email subject line
- Complete and return the Recall Letter Response Form by email.
- For reimbursement, contact Terrific Care by phone at 888-433-2300 or by email at RMA@medexsupply.com
Contact Information
Customers who have questions or need additional information or support related to this recall should email to RMA@medexsupply.com or call a customer service specialist at 888-433-2300 between 9:00 am - 5:00 pm Eastern Standard Time, Monday – Thursday.
Date Recall Initiated
December 21, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
FDA.GOV