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U.S. Department of Health and Human Services

Medical Device Recalls

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cobas® Liat Influenza A/B Quality Control Kit; For use with cobas® Liat Influenza A/B Assay. 3 Jul-13-2016 Roche Molecular Systems, Inc.
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ) 3 Jul-11-2016 GSK Consumer Healthcare
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifi... 3 Jul-08-2016 ORTHO-CLINICAL DIAGNOSTICS
enGen Laboratory Automation System, Product Code engen, Software Versions enGen Select 3.2 and Above... 3 Jul-08-2016 Ortho-Clinical Diagnostics
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VIT... 3 Jul-01-2016 Ortho-Clinical Diagnostics
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a... 3 Jun-20-2016 Leica Biosystems Richmond Inc.
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro dia... 3 Jun-10-2016 Leica Biosystems Richmond Inc.
CytoScan® Dx Assay. The CytoScan Dx Assay consists of five reagent modules, wash buffers (WS), a mic... 3 Jun-03-2016 Affymetrix Inc
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATIO... 3 May-06-2016 Siemens Healthcare Diagnostics, Inc.
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For I... 3 Apr-19-2016 Biocare Medical, LLC

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