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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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MagNA Pure LC 1.0 (software version 3.0.11).
Roche Diagnostics Operations, Inc.
An automated ins...
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2
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08/29/2011
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Roche Diagnostics Operations, Inc.
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MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24)
Roche Diagnostics Operations, Inc.
An aut...
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2
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08/29/2011
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Roche Diagnostics Operations, Inc.
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PCR Eleva Radiological Image Processing System with software R.1.2
Philips Healthcare, Inc.
A c...
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2
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09/14/2011
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Philips Healthcare Inc.
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Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that resul...
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2
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10/14/2011
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Abbott Molecular
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Cobas KRAS Mutation Test for In Vitro Diagnostic Use
Product Usage: Usage:
The Cobas KRAS Mutat...
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3
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08/08/2012
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Roche Molecular Systems, Inc.
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BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 b...
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2
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09/06/2012
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Becton Dickinson & Co.
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BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences C...
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2
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09/06/2012
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Becton Dickinson & Co.
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BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, In...
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2
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09/06/2012
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Becton Dickinson & Co.
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Knee Components:
ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380
INSERT TIBIAL "913...
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2
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10/31/2012
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Wright Medical Technology Inc
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Data Station AMPLILINK software is an instrument user interface/ data management software used with ...
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2
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12/07/2012
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Roche Molecular Systems, Inc.
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