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Biotech / Medical : QDEL - Quidel more quick diagnosis -- Ignore unavailable to you. Want to Upgrade?

To: R. Jaynes who wrote (1626)	11/11/1999 10:58:00 AM
From: George Young	Read Replies (1) \| Respond to of 1693

Anybody here notice this article from last week about Abbott's fine? From what I understand, Abbott is Quidel's main competitor. I also understand that this will result in a bunch of business for Quidel as Abbott customers need to find test kits while Abbott tries to fix its manufacturing process. Anyone confirm this? Abbott Labs To Pay $100M to FDA By LAURAN NEERGAARD AP Medical Writer WASHINGTON (AP) - The nation's largest maker of medical diagnostic tests agreed Tuesday to pay a $100 million fine and stop selling more than 100 of its products until it corrects repeated violations of federal quality rules. Abbott Laboratories (NYSE:ABT - news)' violations date to 1993, said the Food and Drug Administration, which sought a consent decree to settle the issue because Abbott did not correct the problems despite six years of government inspections and warnings. A federal judge in Chicago on Tuesday finalized the consent decree, which addresses some 300 diagnostic products Abbott manufactures - ranging from tests used to ensure the safety of donated blood to tests that detect heart attacks, identify cancerous tumors or measure thyroid problems. Under the consent decree, Abbott is permitted to continue selling only diagnostic tests or devices that the FDA deems medically necessary, about 175 products. Those include tests that detect the AIDS virus and hepatitis in donated blood. The FDA found no evidence that those particular blood tests were inaccurate. As an added safeguard, the FDA reinspects blood before deciding which batches can be transfused. But Abbott is barred from selling 125 other products until manufacturing at its Illinois factory meets federal quality rules. Competitors sell alternatives for each of those tests, and Abbott's sales will stop in 30 days, time to allow laboratories to pick another supplier and restock.