Alere (NYSE:ALR) said it recalled several of its blood clot-testing products over concerns they might provide inaccurate results that could result in serious injury or death.
According to the FDA’s website, Alere issued a recall Dec. 5 for its INRatio and INRatio2 monitors and test strips after receiving reports the devices failed to accurately measure a patient’s international normalized ratio, or INR. The products are used to determine the blood-clotting speed, or prothrombin time, in patients taking the anticoagulant drug warfarin.
The agency added that the readings were more likely to be inaccurate if the patient also had anemia, unusual bruising/bleeding or a condition associated with elevated fibrinogen levels.
The FDA has classified the recall as Class I, meaning that continued use of the devices could result in serious injury or death. The products were manufactured and distributed between April 1, 2008, and Dec. 4, 2014.
Alere has received 18,924 reports of the devices malfunctioning, including 14 reports of serious injury. The company has determined that all of the devices are at risk of failing, according to the FDA.
In Dec. 5 letter to healthcare professionals, Alere warned that the tests not be used on patients with certain medical conditions outlined in the letter. The company also suggested patients be screened for red blood-cell anemia and undergo periodic INR laboratory testing for comparison. Alere also advised the tests only be used on patients who had already been stabilized on warfarin.
“As part of its commitment to ensuring the safety of patients, Alere has reported these device concerns to the U.S. Food & Drug Administration and is conducting a thorough investigation into these events,” according to a press release.
The December recall topped off what had been a tumultuous year for the diagnostics giant.
Last September, former Alere CEO Ron Zwanziger unveiled plans to take the company private in a deal valued at $3.82 billion. Zwanziger abruptly resigned in July as part of a major corporate shake-up that also saw the departures of the company’s chief scientific officer and senior vice president for research and development.
Last week, Alere announced it had completed the sale of its Alere Health division to Optum for $600 million in cash. The company has said it plans to use proceeds from the sale to pay down debt.
