MZVClass II

Test, System, Potassium, Enzymatic Method

Clinical Chemistry · 21 CFR 862.1600

MDR events195All time

Recalls0All time

Registered firms3Currently listed

510(k) clearances4All time

Recent MDR events

195 adverse event reports on file

DIMENSION VISTA 1500Jan 15, 2015
MalfunctionSiemens Healthcare Diagnostics Inc1226181-2015-00026
DIMENSION VISTA 1500Nov 18, 2014
MalfunctionSiemens Healthcare Diagnostics1226181-2014-00594
DIMENSION EXL WITH LMNov 18, 2014
MalfunctionSiemens Healthcare Diagnostics Inc1226181-2014-00589
ARCHITECT C8000 SYSTEMSep 2, 2014
MalfunctionAbbott Manufacturing Inc1628664-2014-00184
ARCHITECT C16000 SYSTEMJun 27, 2014
MalfunctionAbbott Manufacturing Inc1628664-2014-00125
DIMENSION VISTA 1500Jun 5, 2014
MalfunctionSiemens Healthcare Diagnostics Inc1226181-2014-00304
AU5400 CLINICAL CHEMISTRY ANALYZERJun 4, 2014
MalfunctionBeckman Coulter9612296-2014-00084
DIMENSION EXL WITH LMMay 2, 2014
MalfunctionSiemens Healthcare Diagnostics1226181-2014-00242
COBAS 6000 C501 MODULEMay 1, 2014
MalfunctionRoche Diagnostics1823260-2014-03125
UNICEL® DXC 600 SYNCHRON® SYSTEMApr 14, 2014
MalfunctionBeckman Coulter2050012-2014-00200

Event type breakdown

Malfunction184

Injury8

Other2

Death1

Most-reported manufacturers

Instrumentation Laboratory Co.39 Beckman Coulter32 Abbott Manufacturing Inc22 Roche Diagnostics20 Beckman Coulter, Inc.18 Siemens Healthcare Diagnostics Inc14 Beckman Coulter Inc.13 Siemens Healthcare Diagnostics Inc.10

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

3 firms currently registered for this product code

510(k) clearances

4 clearances for this product code