KQGClass II

Instrument, Coagulation

Hematology · 21 CFR 864.5400

MDR events39All time

Recalls1All time

Registered firms5Currently listed

510(k) clearances14All time

Recent MDR events

39 adverse event reports on file

Event type breakdown

Malfunction37

Injury1

Other1

Most-reported manufacturers

International Technidyne Corp.28 International Technidyne Corp2 Toa Medical Electronics2 Instrumentation Laboratories, Inc.1 International Technidyne1 International Technidyne Corporation1 International Tecnidyne Corp1 Itc1

Recalls

1 recall events for this product code

International Technidyne Corp.
TerminatedFeb 11, 2011
Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRF
Some Activated Clotting Time (ACT) Tubes may contain a component that does not meet its specification, making it possible for a failure to detect a tube or the presence of a clot.
Z-1093-2011 · View FDA record ↗

Registered firms

5 firms currently registered for this product code

510(k) clearances

14 clearances for this product code