| Subject: | FDA Issues Recall of Immunoassay Analyzer |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 14 Dec 2004 - 10:00 am |
| The FDA and Tosoh Bioscience, Inc., have issued a Class I recall of Tosoh Bioscience's AIA-600 II Enzyme Immunoassay Analyzer, software version 3.02, due to occurrences of false negative and false positive results. The AIA-600 II Enzyme Immunoassay Analyzer is used in clinical laboratory testing of cardiac markers (such as Troponin levels), tumor markers, thyroid levels and other various assays. The software version 3.02 producing the false results may lead to delay in appropriate diagnosis of... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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