GKJClass I

Spinner, Slide, Automated

Hematology · 21 CFR 864.5850

MDR events105All time

Recalls1All time

Registered firms4Currently listed

510(k) clearances6All time

Recent MDR events

105 adverse event reports on file

CELL-DYN SMSJun 18, 2019
MalfunctionAbbott Diagnostics Division2919069-2019-00074
CELL-DYN SMSNov 16, 2018
MalfunctionAbbott Diagnostics Division2919069-2018-00056
CELL-DYN SMSJun 24, 2016
MalfunctionAbbott Diagnostics Division2919069-2016-00768
CELL-DYN SMSApr 21, 2015
MalfunctionAbbott Diagnostics Division2919069-2015-00020
UNICEL® DXH¿ SLIDEMAKER STAINER COULTER® CELLULAR ANALYSIS SYSTEMApr 11, 2013
MalfunctionBeckman Coulter1061932-2013-00606
COULTER® LH 750 SLIDEMAKERMar 27, 2013
MalfunctionBeckman Coulter1061932-2013-00512
COULTER® LH 750 SLIDEMAKERMar 26, 2013
MalfunctionBeckman Coulter1061932-2013-00471
UNICEL® DXH SLIDEMAKER STAINER COULTER® CELLULAR ANALYSIS SYSTEMMar 18, 2013
MalfunctionBeckman Coulter1061932-2013-00342
COULTER® LH 750 SLIDEMAKERFeb 27, 2013
MalfunctionBeckman Coulter1061932-2013-00239
COULTER LH 750 SLIDEMAKERJun 23, 2012
MalfunctionBeckman Coulter, Inc.1061932-2012-01959

Event type breakdown

Malfunction101

Injury4

Most-reported manufacturers

Beckman Coulter, Inc.72 Beckman Coulter Inc.17 Abbott Diagnostics Division7 Beckman Coulter5 Abbott Diagnostics Division/celldyn3 Medtronic Blood Management1

Recalls

1 recall events for this product code

Beckman Coulter Inc
TerminatedFeb 4, 2006
COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
Z-0475-06 · View FDA record ↗

Registered firms

4 firms currently registered for this product code

510(k) clearances

6 clearances for this product code