41 results
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51ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UF-100I SYSTEM MODULE
FDA Adverse Event
Other
·DATA INNOVATIONS, INC.·Product code KQO·February 6, 2013
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS, INC.·Product code JQP·January 7, 2013
UF100I SYSTEM MODULE
FDA Adverse Event
Other
·DATA INNOVATIONS, INC.·Product code JQP·April 22, 2013
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS, INC.·Product code JQP·September 13, 2007
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS, INC.·Product code JQP·February 20, 2009
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS, INC.·Product code JQP·August 16, 2006
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS, INC.·Product code JQP·December 17, 2013
VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JQP·March 6, 2006
Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
FDA Recall
Terminated
·Data Innovations, Inc.·Product code JQP·May 11, 2009
Roche Cobas driver (rchcob6i), analytical laboratory data interface.
FDA Recall
Terminated
·Data Innovations, Inc.·Product code JQP·November 3, 2006
Roche Modular Drive (rchmdlri), analytical laboratory data interface.
FDA Recall
Terminated
·Data Innovations, Inc.·Product code JQP·November 3, 2006
Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)
FDA Recall
Terminated
·Data Innovations, Inc.·Product code JQP·August 10, 2006
Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
FDA Recall
Terminated
·Data Innovations, Inc.·Product code JQP·November 6, 2013
SHOWER CHAIR
FDA Adverse Event
Malfunction
·INNOVATIVE PRODUCTS·September 15, 1993
Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004
FDA Enforcement
Class II
·Terminated·Data Innovations, Inc.·January 1, 2014
COULTER FC500 FLOW CYTOMETER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·November 15, 2011
INSTRUMENT MANAGER SOFTWARE
FDA Adverse Event
Malfunction
·DATA INNOVATIONS LLC·Product code JQP·July 8, 2019
JRESULTNET USING PROVUE DRIVER V1.5.3 OR LOWER
FDA Adverse Event
Malfunction
·DATA INNOVATIONS LLC·Product code JQP·August 22, 2014
FC 500 WITH UPS
FDA Adverse Event
Other
·BECKMAN COULTER, INC.·Product code LXG·August 16, 2007
TOSOH HLC-723G8 ANALYZER G8
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code LCP·March 23, 2018