More than 800,000 heart meters used to detect heart attacks are being recalled by Waltham, MA-based Alere ($ALR) after FDA inspectors found manufacturing and labeling issues at its San Diego plant.
The company says the recall will limit supplies of the tests for an unknown time. It has worked a deal with the FDA to continue to make them under special guidelines until new procedures can be implemented this fall. The company is trying to crank up production under the new oversight plan to cover the shortfall, Reuters reports. The recall includes unexpired lots of Alere Triage cardiology products in the U.S., but customers who don't have an alternate method to test are being permitted to use the recalled panels.
According to an SEC filing, Alere says the recall effects its Triage line of meters but that it also will be making adjustments in the manufacturing of its Alere Triage TOX Drug Screen tests. It says, "Alere is unable to determine the scope of any potential recall or the financial implications of the revised release methods."
The devicemaker last month reported a quarterly loss of $4.1 million related to last year's hostile takeover of medical diagnostic kit maker Axis-Shield. It says in Wednesday's disclosure that the cost of increasing production to try to cover the recall will affect future earnings, an announcement that has further dampened the price of its shares, which were down as much as 4% Wednesday.
- read the Reuters piece
- get more from Bloomberg
- here's the SEC filing with the details