Alere Inc Starts Recall Of Cardiology Test Lots-Reuters
Reuters reported that Alere Inc, said it started a recall of about 104 lots of its Triage cardiology products as they do not satisfy a particular quality control method as prescribed by U.S. health regulators. Alere earlier this month warned of a need to recall after the U.S. Food and Drug Administration inspected its San Diego facility in March and questioned labeling and quality control method of its Triage products. Alere expects to have limited inventory of its Triage cardiology panels for an unknown duration of time, but said it was "significantly increasing production" and sees a related increase in manufacturing costs from the second quarter of 2012. The recall covers unexpired lots of Alere Triage cardiology products sold in the United States, but allows customers who do not have an alternate testing method to continue using these lots.
- Share this
- Digg this