LOQClass II

Device, General Purpose, Hematology

Immunology · 21 CFR 866.6010

MDR events88All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances1All time

Recent MDR events

88 adverse event reports on file

COULTER LH 750 SLIDEMAKER ANALYZERJun 27, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00767
COULTER LH 750 ANALYZERJun 20, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00711
COULTER LH 750 ANALYZERJun 20, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00712
COULTER LH 750 ANALYZERJun 20, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00713
COULTER LH 750 SLIDEMAKER ANALYZERJun 20, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00710
COULTER LH 750 ANALYZERJun 6, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00559
COULTER LH 750 ANALYZERJun 6, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00561
COULTER LH 750 SLIDEMAKER ANALYZERJun 6, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00564
COULTER LH 750 HEMATOLOGY ANALYZERMay 13, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00409
COULTER LH 750 ANALYZERMay 12, 2011
MalfunctionBeckman Coulter, Inc.1061932-2011-00404

Event type breakdown

Malfunction80

Injury7

Unspecified1

Most-reported manufacturers

Beckman Coulter, Inc.53 Beckman Coulter Inc.28 Boehringer Mannheim Corporation-freemont2 Biomet Biologics1 Boehringer Mannheim Corporatooon-freemont1 Boehringer Mannhiem Corporation-freemont1 Roche Diagnostics1 Unknown1

Recalls

1 recall events for this product code

Beckman Coulter Inc
TerminatedJul 18, 2006
Coulter LH500 Hematology Analyzer: Part Numbers 178832, 178833, 178834
Beckman has confirmed that erroneous results could be reported when the workstation database crashes.
Z-1245-06 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

1 clearances for this product code

Chiron Diagnostics Corp.Jul 7, 1998
K981592 · ACS:CENTAUR AFP