10,000 results · 43ms · Sources: EU EUDAMED, 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