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Alere INR Home Monitoring

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Kershaw, Cook & Talley is investigating the Alere InRatio® PT/INR Monitor System recall. The Alere InRatio PT/INR Monitor System is a device designed for individuals taking a prescription anticoagulation medication (like Coumadin or warfarin) to self-test their PT/INR, or blood clotting levels.  According to the Food and Drug Administration (FDA), the recall was issued due to certain cases in which an INRatio and INRatio2 PT/INR Monitor system provided a falsely low INR reading. The FDA recommends patients with any of the following conditions stop using the device:

  • Anemia
  • Acute inflammatory conditions (e.g. pneumonia or influenza)
  • Chronic inflammatory conditions (e.g. rheumatoid arthritis, Crohn’s disease, ulcerative colitis, infectious liver diseases such as hepatitis, or inflammatory kidney diseases such as diabetic nephropathy and glomerulonephritis)
  • Severe infection (e.g., sepsis)
  • Chronically elevated fibrinogen
  • Hospitalized or advanced stage cancer or end stage renal disease patients requiring hemodialysis
  • Any bleeding or unusual bruising, clinically observed or reported by the patient

Patients with any condition requiring the use of the device should immediately notify their health care professional. It is recommended the patient transition to a laboratory INR method for monitoring their INR and anticoagulation therapy.

If you, or a loved one, use the Alere INR Home Monitoring, contact an experienced personal injury attorney at Kershaw, Cook & Talley.

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