GKNClass II
Timer, Clot, Automated
Hematology · 21 CFR 864.5400
MDR events327All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All time
Recent MDR events
327 adverse event reports on file
- ACT Plus InstrumentJul 27, 2026MalfunctionPerfusion Systems2184009-2026-01078
- ACT PLUS INSTRUMENTJul 22, 2026MalfunctionPerfusion Systems2184009-2026-01046
- ACT PLUS INSTRUMENTJul 9, 2026MalfunctionPerfusion Systems2184009-2026-00767
- ACT PLUS INSTRUMENTJul 9, 2026MalfunctionPerfusion Systems2184009-2026-00768
- ACT PLUS INSTRUMENTJul 9, 2026MalfunctionPerfusion Systems2184009-2026-00769
- ACT PLUS INSTRUMENTJul 9, 2026MalfunctionPerfusion Systems2184009-2026-00770
- ACT PLUS INSTRUMENTJun 12, 2026MalfunctionPerfusion Systems2184009-2026-00614
- ACT PLUS INSTRUMENTJun 11, 2026MalfunctionPerfusion Systems2184009-2026-00611
- ACT PLUS INSTRUMENTJun 10, 2026MalfunctionPerfusion Systems2184009-2026-00607
- ACT PLUS INSTRUMENTJun 3, 2026MalfunctionPerfusion Systems2184009-2026-00595
Event type breakdown
Malfunction319
Injury8
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code