MSYClass IILife-sustaining

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Gastroenterology, Urology · 21 CFR 876.5665

MDR events38All time

Recalls0All time

Registered firms10Currently listed

510(k) clearances13All time

Recent MDR events

38 adverse event reports on file

QUANTI MATRIX DROPPERJul 14, 2011
MalfunctionCrunin Diagnostics Ltd.MW5021351
STERICHEK TOTAL CHLORAMINE AND RESIDUAL CHLORINESep 3, 2008
InjuryHach Company1153743
STERICHEK SENSITIVE TOTAL CHLORAMINES AND RESIDUAL CHLORINE REAGENT STRIPSJun 6, 2008
InjuryHach Company1833407-2008-00001
HACH STERICHEK TOTAL CHLORINE REAGENT STRIPSMay 22, 2008
InjuryHach Company1048124
HACH STERICHEK TOTAL CHLORINE REAGENT STRIPSMay 22, 2008
InjuryHach Company1048125
HACH STERICHEK TOTAL CHLORINE REAGENT STRIPSMay 22, 2008
InjuryHach Company1048126
HACH STERICHEK TOTAL CHLORINE REAGENT STRIPSMay 22, 2008
InjuryHach Company1048127
HACH STERICHEK TOTAL CHLORINE REAGENT STRIPSMay 22, 2008
InjuryHach Company1048128
HACH STERICHEK TOTAL CHLORINE REAGENT STRIPSMay 22, 2008
InjuryHach Company1048129
HACH STERICHEK TOTAL CHLORINE REAGENT STRIPSMay 22, 2008
InjuryHach Company1048130

Event type breakdown

Injury34

Death3

Malfunction1

Most-reported manufacturers

Hach Company35 Baxter Healthcare Corp.1 Crunin Diagnostics Ltd.1 Fresenius Medical Care1 Gambro1 Minntech Corp1 Minntech Corp.1 Siemens Healthcare Diagnostics Inc.1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

10 firms currently registered for this product code

510(k) clearances

13 clearances for this product code