[MOL] Abbott Labs to pay $100 mln to FDA [00615] Medicine On Line

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[MOL] Abbott Labs to pay $100 mln to FDA

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*** Abbott Labs to pay $100 mln to FDA

WASHINGTON (AP) - The nation's largest maker of medical diagnostic
tests, Abbott Laboratories, has agreed to pay the government $100
million and temporarily stop selling dozens of tests under a consent
decree to settle repeated violations of quality manufacturing rules.
A federal judge in Chicago finalized the decree Tuesday. The
violations date to 1993, the Food and Drug Administration said.
Repeated warnings of uncorrected violations every year since
culminated in Tuesday's court action, the FDA said. Abbott is not
required to recall any tests, and patients who had their blood or
other tissue samples tested at a laboratory using Abbott products are
not advised to be retested, the FDA said. "The issues have to do with
manufacturing processes and not with known instances of patient
harm," said FDA medical devices chief Dr. David Feigal. See
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