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Abbott Gets Into Hot Water

The $100 million consent decree that Abbott Diagnostics signed with the Food and Drug Administration in early November took many in the diagnostics industry by surprise and has left them shaken.

As the world's largest provider of immunoassay systems and tests, with a market share that seems unassailable, Abbott Laboratories Inc. 's diagnostics business has fared comparatively well during a period of industry turmoil. But the $100 million consent decree it signed in early November with the Food and Drug Administration has left the diagnostics industry shaken.

As most people in diagnostics know by now, the FDA accuses Abbott of failing to comply with Good Manufacturing Practices and quality system regulation, despite repeated warnings. It ordered Abbott...

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