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News From the Food and Drug Administration
January 5, 2000

Injunction Affecting Abbott's in Vitro Test Devices

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JAMA. 2000;283(1):46. doi:10.1001/jama.283.1.46

Abbott Laboratories, Abbott Park, Ill, has entered into a consent decree of permanent injunction with the Department of Justice affecting 242 in vitro diagnostic devices manufactured by Abbott's Diagnostic Division in Abbott Park and its K2 facility in North Chicago, Ill. A total of 178 of these devices that the FDA identified as medically necessary continue to be available while their manufacturing is being brought into compliance with the FDA's Quality System regulation; the remaining 64 devices will not be distributed following a transition period to allow users to standardize or obtain alternative test methods.