Heart Attack Detector Recalled For Not Meeting FDA Standards
A device that is used to detect whether a heart attack has taken place has been recalled because certain lots of the device fail to adhere to mandated guidelines.
The Waltham, Massachusetts-based Alere Inc. announced the recall of their Alere Triage BNP, Alere Triage D-dimer, and Alere Triage cardiololoy panels. 104 lots in total are affected by the recall, encompassing a whopping 803,000 of the tests. Each of the items was manufactured in either 2011 or the first quarter of this year.
In addition to detecting heart attacks, the devices in question are also used by doctors to help manage the treatment of those persons who have suffered some sort of heart failure. The recall had to be initiated because, according to the company, regulations set forth by the Food and Drug Administration were not met by the devices in question.
Despite the recall, Alere is being allowed to continue to manufacture the tests this month and throughout June. This manufacturing process will happen, though, under a new quality control system being put in in place. This system is only temporary at the moment, and the company is currently discussing how to get something more permanent up and running. Alere has also increased production to offset the loss of those items that are being taken off the market.
There has been no word on if anyone experienced an adverse event in conjunction with the items being recalled.