A Brighter Future: The Abbott Diagnostics Recovery

Originally Published MX July/August 2005

COVER STORY

Abbott is one of the big-seven companies in the in vitro diagnostics (IVD) sector of the medical device industry and a global leader in the field of immunoassay testing. But in November 1999 Abbott's diagnostics business ran into some significant challenges.

That month, Abbott signed a consent decree because of ongoing issues regarding FDA's quality systems regulation at its plant in Lake County, IL. In addition, the company agreed to cease production of a significant number of assays manufactured at the plant.

It took several years, but Abbott managed to get its diagnostics business back on track. At the beginning of 2004, FDA cleared the Lake County facility to produce some of the previously stopped assays, gradually permitting the facility to return to normal operations.