During the second quarter, we continued to work with the FDA to establish a plan around revised release specifications for the Triage products manufactured in San Diego. During the quarter, we began tightening our release specifications in accordance with the plan agreed to with the FDA and, while the adjustments are still generating supply issues, we continue to be increasingly confident that once our manufacturing processes are optimized we will be able to cost-effectively meet market demand in the U.S. for our Triage panels.Nonetheless, despite having more than doubled our production capacity, with further increases planned, we do expect supply issues mainly in the U.S. with certain tests, primarily the Cardiology panels. This situation is likely to persist through the remainder of the third quarter and into the fourth quarter, as we continue to work through our manufacturing process changes.
Alere's CEO Discusses Q2 2012 Results - Earnings Call Transcript
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