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U.S. Department of Health and Human Services

Safety

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Tosoh Bioscience AIA-600 II Analyzer

Audience: Clinical laboratory specialists and healthcare professionals

FDA and Tosoh Bioscience, Inc. notified healthcare professionals of a Class 1 recall of the Tosoh Bioscience AIA-600 II Enzyme Immunoassay Analyzer, software version 3.02. This laboratory analyzer is used by laboratory professionals to measure thyroid hormones, cardiac markers including troponin, tumor markers, as well as several other assays. This analyzer, with software version 3.02, produced occurrence of false positive and false negative results which could lead to aggravation of the patient's clinical condition, delay in treatment and potentially death.

[December 2, 2004 - Recall Notice - FDA]