25 results
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62ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·July 18, 2014
CellQuest Pro SW, version 4.0.2. and later; Becton Dickinson, San Jose, CA 95131 CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·September 7, 2007
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code OYE·June 6, 2014
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code MVU·December 19, 2014
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·June 29, 2012
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·June 15, 2015
CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKL·December 19, 2014
BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·February 19, 2010
BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166, Product is manufactured and distributed by BD Biosciences, San Jose, CA The reagents are for in vitro diagnostic use on a BD FACSCount instrument.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·January 29, 2009
BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA. CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to 220 kilodaltons (kDa).
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code MVU·November 23, 2009
BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code GKZ·February 19, 2010
BD FACS Sample Prep Assistant (SPA and SPA II) Instrument, Model Number: 334080, Product is manufactured and distributed by BD Biosciences, San Jose, CA The intended use for the BD FACS Sample Prep Assistant (SPA and SPA II) is to prepare human whole blood for flow cytometry.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code JQW·January 3, 2009
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code MVU·April 4, 2014
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code OYE·March 6, 2015
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
FDA Recall
Terminated
·BD Biosciences, Systems & Reagents·Product code MVU·March 23, 2015
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·July 9, 2014
Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·May 7, 2014
BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·September 26, 2012
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
FDA Enforcement
Class II
·Terminated·BD Biosciences, Systems & Reagents·April 8, 2015
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
FDA Enforcement
Class III
·Terminated·BD Biosciences, Systems & Reagents·July 22, 2015