The Alere INRatio PT/INR monitor system was developed and marketed originally by the biotechnology firm HemoSense. The FDA approved the monitor system for home use in October 2002 and commercial sales began in early 2003. Inverness Medical Innovations, Inc., now Alere Inc., purchased HemoSense in August of 2007. The sales for the INRatio were extremely successful, with sales of $3.25 million in 2004 and $16.26 million by 2006.

In 2005, the FDA publicly warned HemoSense, after they reviewed the test strips and test meters, that there were serious regulatory problems. Specifically, HemoSense had failed to provide information that the device (1) may have caused or contributed to a death or serious injury; or (2) has malfunctioned and that device or a similar device marketed would likely cause or contribute to a death or serious injury if the malfunction were to recur.   The FDA discovered that the devices were “generating clinically significant erroneous values” and that these erroneous INR values could result in serious and even deadly bleeding events.

In 2006, the FDA investigated HemoSense again regarding the INRatio test strips. The test strips, which were authorized for a 15 month shelf life, had packaging that indicated a 12 month shelf life. The company thus ignored any complaints regarding the test strips if it fell outside 12 months. The FDA again warned HemoSense of the failure to investigate the complaints.

Then in 2014, Alere issued a recall of the INRatio test strips in April and in December of 2014 it recalled the INRatio and INRatio 2 PT/INR monitor systems.  This is after Alere received almost 19,000 complaints about malfunctions with its monitoring systems. These complaints included three deaths and six serious bleeding injuries.

Alere states in its recall letter that the systems should not be used on patients with any of the following conditions:

  • Anemia of any type with hematocrit (percentage of red blood cells in the blood) less than 30%
  • Any conditions associated with elevated fibrinogen levels
  • Any bleeding or unusual bruising, clinically observed or reported by the patient

Early in 2015, the FDA then classified the recall as a Class I, and defines a Class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”