| Subject: | FDA Issues Class 1 Recall of Ortho-Clinical Diagnostics HBsAg Confirmatory Kit |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 13 Jan 2006 - 10:00 am |
| On January 9, 2006 Ortho-Clinical Diagnostics and FDA notified healthcare professionals and clinical laboratory staff of a Class 1 recall of the HBsAg Confirmatory Kit due to an unknown component in the diluting solution used to test blood and serum samples that may produce 'Not Confirmed' results for samples found to be positive with the initial test. This can cause some results to be classified as false negatives.
False negative results may prevent some patients infected with or carrying... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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