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October 16, 2002
Company: Roche Diagnostics CorpDate of Enforcement Report: 10/16/02 Class: II PRODUCT Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3. REASON Possibile incorrect breast cancer marker results. CODE Serial numbers 1058-11, 1164-70 and 0806-10. (All analyzers with software version 06-01.) RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8,...
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