Home › Device types › GKT
Separator, Automated, Blood Cell, Diagnostic
FDA product code GKT · Class 2 · Hematology
173
Registered devices
6,575
Adverse events
1
Recalls
10
510(k) clearances
Devices with this code
Spectra Optia® — TERUMO BCT, INC.COBE® Spectra — TERUMO BCT, INC.MCS+ — HAEMONETICS CORPORATIONRika Plasma Donation System — TERUMO BCT, INC.MCS 9000 — HAEMONETICS CORPORATIONCOBE® Spectra — TERUMO BCT, INC.Trima Accel® — TERUMO BCT, INC.Trima Accel® — TERUMO BCT, INC.Platelet Additive Solution Connection Adapter — TERUMO BCT, INC.ALYX™ RBC/Plasma Kit — FENWAL, INC.Fenwal AMICUS Apheresis Kit- SingleNeedle w/Platelet Additive Solution Connector — Fresenius Kabi AGHAEMONETICS MCS+ (LN9000) APHERESIS SYSTEM — HAEMONETICS CORPORATIONSpectra Optia® — TERUMO BCT, INC.PLASMACELL Xi Disposable Set with SPIKESMART — Fresenius Kabi AGAMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly — Fresenius Kabi AGMCS+ — HAEMONETICS CORPORATIONAMICUS Separator — Fresenius Kabi AGHaemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems — HAEMONETICS CORPORATIONCOBE® Spectra — TERUMO BCT, INC.AMICUS Separator Software — Fresenius Kabi AGALYX RBC/PLASMA KIT — Fresenius Kabi AGAmicus Single Needle Advanced Kit with Platelet Additive Solution Connector — Fresenius Kabi AGSpectra Optia® — TERUMO BCT, INC.Haemonetics® PCS®2 & NexSys PCS® Systems — HAEMONETICS CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-25 | Fenwal Inc | Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols |
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