Home › Device types › GKT
Separator, Automated, Blood Cell, Diagnostic
FDA product code GKT · Class 2 · Hematology
173
Registered devices
6,589
Adverse events
1
Recalls
10
510(k) clearances
Devices with this code
AMICUS Separator — Fresenius Kabi AGAccessory Platelet Bag with Integrated Sampler — TERUMO BCT, INC.Trima Accel® — TERUMO BCT, INC.Trima Accel® — TERUMO BCT, INC.Rika Plasma Bottle — TERUMO BCT, INC.Aurora Xi — Fresenius Kabi AGTrima Accel® — TERUMO BCT, INC.MCS+ (LN8150) RBC APHERESIS — HAEMONETICS CORPORATIONHaemonetics® PCS®2, NexSys PCS™ & MCS®+ Systems — HAEMONETICS CORPORATIONCOBE® Spectra — TERUMO BCT, INC.ALYX 2RBC-LR Kit with Saline Spike — Fresenius Kabi AGAMICUS Separator — Fresenius Kabi AGTrima Accel® — TERUMO BCT, INC.ALYX Component Collection System — Fresenius Kabi AGALYX 2RBC LR KIT — Fresenius Kabi AGSpectra Optia® — TERUMO BCT, INC.Rika Plasma Separation Set — TERUMO BCT, INC.AMICUS Separator Life Extension Software — Fresenius Kabi AGTrima Accel® — TERUMO BCT, INC.Trima Accel® — TERUMO BCT, INC.Fenwal AMICUS Single Needle Advanced Kit — Fresenius Kabi AGPLASMACELL Xi Disposable Set with SPIKESMART — Fresenius Kabi AGHAEMONETICS MCS+ (LN8150) for RBC APHERESIS — HAEMONETICS CORPORATIONTrima Accel® — TERUMO BCT, INC.
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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