186 results
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44ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·August 4, 2010
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·August 4, 2010
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·March 24, 2011
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·March 24, 2011
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·March 24, 2011
Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class III
·Terminated·Clinical Diagnostic Solutions·November 14, 2012
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Recall
Terminated
·Clinical Diagnostic Solutions·Product code JPK·February 24, 2013
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Recall
Terminated
·Clinical Diagnostic Solutions, Inc.·Product code GKZ·January 2, 2020
Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. Siemens Material Number (SMN) :11066000
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·February 6, 2019
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
FDA Enforcement
Class II
·Terminated·Clinical Diagnostic Solutions·April 16, 2014
Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·May 9, 2018
BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 3, 2019
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Enforcement
Class II
·Terminated·Clinical Diagnostic Solutions, Inc.·February 12, 2020