197 results
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51ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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 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 Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JGS·February 26, 2018
Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 29, 2018
Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 29, 2018
Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 29, 2018
Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 29, 2018
Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 29, 2018
Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JJE·June 29, 2018
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150
FDA Recall
Open, Classified
·Becton Dickinson & Co.·Product code JQP·September 12, 2024
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 Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIT·September 26, 2018
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 Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIT·September 26, 2018
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 Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIT·September 26, 2018
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 Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIT·September 26, 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 Recall
Terminated
·Becton Dickinson & Co.·Product code JQP·February 21, 2019