The FDA has identified this as a Class I recall, the most serious type of recall. 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, are 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.
If you suspect that you have used a defective test strip, please call us today for a free consultation.