CoaguChek Recall: What You Need To Know

Warfarin sodium (Coumadin or Marevan) is the most widely used anticoagulant in the United States. This medication is vital for patients with venous thromboembolism, chronic atrial fibrillation, valvular heart disease, and mechanical prosthetic heart valves. However, due to the risk of internal hemorrhaging, monitoring is required every one to four weeks to ensure appropriate dosing.

Until 2000, when CoaguChek portable monitors received FDA approval, patients had to make recurring appointments with a healthcare provider to test their International Normalized Ratio (INR). CoaguChek allows individuals the ability to conveniently measure at home, using a lancing device to obtain one whole drop of blood onto a test strip, with results visible within one minute.

However, the U.S. Food and Drug Administration warns patients and doctors that these strips are providing inaccurate results with potentially fatal ramifications. On September 13, 2019, the FDA announced a Class I recall for warfarin test strips manufactured by Roche Diagnostics. On February 1, 2019, another Class I recall was announced for test strips made by Terrific Care and Medex Supply. Class I recalls are the most serious type, indicating that use of the device may cause serious injury or death.

What Is the CoaguChek Recall?

The Coaguchek Recall applies to:

  • More than one million packages of CoaguChek XS PT test strips (manufactured and distributed from January 12, 2018 – October 29, 2018) with lot numbers: 28124111, 28124121, 28631911, 28631921, 28631924, 28632021, 28632213, 28632312, 28632412, 29415113, 29415123, 29494221, 29494312, 29494613, 29494711, 29778721, 29779012, 29779213, 29779214, 30497213, 30497311, 30497413, 30497423, 30497515, 31404314, 31404821, 32264116, 32264212, 32264316, 32264317, 32264411, 32264421, 33045913, 33046011, 33046113, 33046312, 33046314, 33046321, 33046322, 33449612, 33449712, 33449723, 33449817. The strips can be used with CoaguChek XS Plus, CoaguChek XS Pro, CoaguChek XS Professional, CoaguChek XS PST, and CoaguChek Vantus test meters.
  • All lot numbers of test strips sold by Terrific Care LLC or Medex Supply (October 2017 – December 2018).

According to Pharmacy Times, “These strips were not labeled or authorized for sale in the United States and were only distributed by Roche Diagnostics outside the country. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source, imported these products, and sold them in the United States.”

Using faulty strips could lead to errors in medication dosage that increase the risk of blood clots, especially in patients with mechanical heart valves, irregular heartbeat, stroke risk, or a history of blood clots.

Adverse Warfarin Symptoms to Look Out For

Warfarin patients should be attentive for signs and symptoms of a bleeding episode, stroke, or blood clot.

Bleeding episode symptoms include:

  • Red or tarry stools
  • Red or brown urine
  • Extensive bruising
  • Coughing or vomiting blood
  • Excessive menstrual bleeding
  • Uncontrolled bleeding from the nose or gums
  • Cuts that don’t stop bleeding with applied pressure
  • Poor appetite, diarrhea, cramping, or vomiting for more than 24 hours

Stroke symptoms include:

  • Dizziness
  • Visual changes
  • Severe headache
  • Numbness or weakness in any limb
  • Slurred speech or difficulty speaking.

Lastly, patients must monitor their health symptoms for signs of a clot, such as:

  • Chest pain
  • Shortness of breath
  • Redness, swelling, heat, or pain in any limb.

Individuals using the CoaguChek monitors should alert a healthcare provider or visit the emergency room immediately if they experience any of these adverse events associated with improper warfarin dosing, as they could be potentially fatal.

What Should You Do If Your CoaguChek Strips Were Recalled?

  • Stop using the faulty strips. Patients and health care providers who are using the CoaguChek system should immediately stop using the test strips.
  • Use an alternative method. Rather than relying on test meter devices for monitoring, patients should have blood drawn from a vein, with levels measured using standard laboratory tests.
  • Make a switch. Roche Diagnostics will provide customers and service providers with new batches of test strips calibrated to the previous international standard within one month.
  • Get more information. If you have any questions about the CoaguChek recall, you can call Roche Diagnostics at 1-800-428-4674.
  • Report adverse events. You can report health problems caused by the device to the FDA’s Adverse Event Reporting Program online. Reporting is essential to give regulators an adequate picture of the harm done by a recalled product.
  • Contact a lawyer. Chaffin Luhana is fielding inquiries from individuals harmed by faulty, recalled CoaguChek strips.

Medical device manufacturers have a legal responsibility to release safe, well-tested products to market. When they fail to do so and another person is harmed, they owe a duty of care. You may have grounds to file a CoaguChek lawsuit, which could result in compensation for your medical bills and lost wages, as well as additional money for emotional pain and suffering. Those who have lost a loved one due to stroke or an uncontrolled bleeding event can file a wrongful death lawsuit to receive compensation for medical bills, burial costs, funeral expenses, and loss of companionship, guidance, or support.

Additional Resources:

  1. https://www.uspharmacist.com/article/the-coaguchek-s-system
  2. https://www.fda.gov/medical-devices/medical-device-recalls/roche-diagnostics-recalls-coaguchek-xs-pt-test-strips-due-inaccurate-inr-test-results