Alere Previously Warned About Potential Problems with INRatio Devices
Although Alere INRatio devices and Testing Strips were recalled in 2014, Alere had knowledge of the dangerous inaccuracies of their devices for more than 10 years. In 2005 and 2006, the FDA issued warning letters to Hemosense, the manufacturer of the INRatio device at that time. In their warning letters, the FDA noted that Hemosense had received complaints about the INRatio devices producing inaccurate readings.
The 2005 warning letter to Hemosense informed the company that they had failed to furnish material required under the Medical Device Reporting (MDR) regulation. Under the MDR regulation, companies are required to report (within 30 days) information that suggests their device may have caused or contributed to a death or serious injury, or has malfunctioned and would cause or contribute to serious injury or death if it were to happen again. Hemosense had received notice of INRatio devices being dangerously inaccurate, but failed to report it.
In November of 2006, the FDA issued an additional warning letter to Hemosense outlining the many violations Hemosense had committed. Some of the violations the FDA noted in their warning letter to Hemosense included the company’s failure to review, evaluate, and investigate complaints that are MDR reportable, failing to investigate complaints involving the failure of an INRatio Device, labeling, or packaging to meet the standards set forth by federal law, and failing to ensure all employees were adequately trained for their job.
Unfortunately, even though the FDA warned Hemosense about the possibility that INRatio devices were inaccurate and dangerous, it still took over 10 years after the warning letters for the company to finally issue a recall. Products like the INRatio devices should not remain on the market for more than 10 years after suspecting they are defective, and profits should never be more important than human lives.
If you or a loved one have suffered a serious bleed because of an INRatio device, contact the Merman Law Firm today for immediate assistance.