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BD Biosciences, Systems & Reagents

14 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto I recall (Z-2090-2015)BD Biosciences, Systems & Reagents2015-07-16
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use. recall (Z-1370-2015)BD Biosciences, Systems & Reagents2015-06-26
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent recall (Z-1375-2015)BD Biosciences, Systems & Reagents2015-04-02
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color dir recall (Z-1000-2015)BD Biosciences, Systems & Reagents2015-01-20
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytom recall (Z-1002-2015)BD Biosciences, Systems & Reagents2015-01-20
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process contro recall (Z-2233-2014)BD Biosciences, Systems & Reagents2014-08-14
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vit recall (Z-1977-2014)BD Biosciences, Systems & Reagents2014-07-02
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial recall (Z-1536-2014)BD Biosciences, Systems & Reagents2014-05-01
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Bead recall (Z-2397-2012)BD Biosciences, Systems & Reagents2012-09-17
CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest recall (Z-1845-2011)BD Biosciences, Systems & Reagents2011-03-30
BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jo recall (Z-0397-2011)BD Biosciences, Systems & Reagents2010-12-02
BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, recall (Z-0316-2011)BD Biosciences, Systems & Reagents2010-11-03
BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow recall (Z-1940-2010)BD Biosciences, Systems & Reagents2010-06-30
BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P recall (Z-1007-2010)BD Biosciences, Systems & Reagents2010-04-16

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Every clearance here is in the API, with alerts when new ones post.