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U.S. Department of Health and Human Services

Medical Device Recalls

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Siemens RAPIDPoint® 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPID... 3 Aug-19-2016 Siemens Healthcare Diagnostics Inc
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique ... 3 Aug-17-2016 ORTHO-CLINICAL DIAGNOSTICS
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FIT... 3 Aug-09-2016 Becton, Dickinson and Company, BD Biosciences
Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole b... 3 Aug-05-2016 C.R. Bard, Inc.
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The produc... 3 Aug-03-2016 C.R. Bard, Inc.
AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup... 3 Aug-01-2016 Branan Medical Corporation
Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as one set/package. T... 3 Jul-25-2016 Tosoh Bioscience, Inc.
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extr... 3 Jul-22-2016 Alere San Diego, Inc.
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of b... 3 Jul-22-2016 Alere San Diego, Inc.
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rap... 3 Jul-22-2016 Alere San Diego, Inc.

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