10,000 results
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43ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KINGFISHER DNA EXTRACTOR THERMO FISHER
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC·Product code LXG·October 16, 2020
IMMULITE 2000
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LGD·July 16, 2013
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Enforcement
Class II
·Terminated·Sysmex America, Inc.·April 22, 2020
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back in magazines.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code LXG·March 9, 2020
STREAMLAB ANALYTICAL WORKCELL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code LXG·October 31, 2016
BAXTER IV FLUID BAGS
FDA Adverse Event
Malfunction
·BAXTER INTERNATIONAL INC·Product code LXG·December 28, 2016
THERMO SCIENTIFIC
FDA Adverse Event
Malfunction
·THERMO FISHER SCIENTIFIC·Product code LXG·February 27, 2012
PANTHERA-PUNCHER 9
FDA Adverse Event
Malfunction
·WALLAC OY·Product code LXG·June 26, 2014
STREAMLAB ANALYTICAL WORKCELL
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code LXG·May 15, 2014
AUTOPURE LS
FDA Adverse Event
Injury
·GENTRA SYSTEMS, INC.·Product code LXG·March 4, 2004
FC 500 WITH RXP SW V1.0
FDA Adverse Event
Other
·BECKMAN COULTER INC.·Product code LXG·February 6, 2004
TECAN FE500
FDA Adverse Event
Other
·TECAN CH.·Product code LXG·March 3, 2004
TECAN GENESIS
FDA Adverse Event
Malfunction
·TECAN US·Product code LXG·March 5, 2004
TECAN GENESIS
FDA Adverse Event
Malfunction
·TECAN US·Product code LXG·March 5, 2004
AUTOPURE LS
FDA Adverse Event
Malfunction
·GENTRA SYSTEMS, INC.·Product code LXG·March 4, 2004
TECAN GENESIS
FDA Adverse Event
Malfunction
·TECAN USA·Product code LXG·March 5, 2004
VERSACELL SAMPLE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code LXG·April 29, 2014
MINIBAG PLUS CONTAINER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code LXG·November 22, 2017
SERO-FUGE 2001 CENTRIFUGE 1 SPEED WITH 12-PLACE HEAD
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code LXG·November 10, 2017
BGS PLATELET SEPARATION SYSTEM
FDA Adverse Event
Injury
·.·Product code LXG·November 30, 2017