Alere ($ALR) entered uncertain territory this week as it launches a recall for 104 lots of its cardiac diagnostic tests (803,000 in all), following FDA concerns over quality control methods used during production. Investors weren't pleased, as Reuters and Bloomberg reported, and the news knocked the company's share price down a few percentage points before recovering slightly. The stock traded at $18.32 early Thursday.
News of the recall comes from the Waltham, MA company's recent regulatory filing. Here are the affected products: the Alere Triage BNP, Triage D-dimer and Triage cardiology tests, manufactured in 2011 and the 2012 first quarter. The tests help diagnose heart attacks and also manage heart failure patients. Alere will boost production to cover any market gaps created by the recall and said it will work with customers to manage the issue.
Alere says it is also talking to the FDA about how to resolve quality control issues for the affected Triage products, applicable after June 30. For now, however, regulators are considering Alere's proposal for an interim solution that would be in effect through Sept. 30.
FierceMedicalDevices unsuccessfully attempted to reach an Alere spokesperson for comment. Alere reported $672.4 million in net revenue for its 2012 first quarter, versus $582.5 million over the same period in 2011. Much of the growth came through professional diagnostics acquisitions. But Alere lost $4.1 million for the quarter, compared to $8.1 million in net income in the 2011 first quarter.
- read the regulatory filing
- check out the Bloomberg story
- and here's Reuters' take