January 10 is D-Day for Abbott Laboratories Inc. to pull 125 diagnostics tests off the market as part of its consent decree with the FDA (See "Abbott Gets into Hot Water," IN VIVO, November 1999). The decree, which follows the FDA's accusation that Abbott used shoddy manufacturing processes in its main US-based manufacturing plants, is unprecedented—and hurts far more than Abbott alone.
Given that Abbott controls 40-50% of the immunoassay market worldwide, the decree places a significant burden on customers. According to...
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