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DXT Data Management System
Fresenius Kabi AG · Model 3.0 · UDI-DI 04086000101578
GKT
Prescription
10
510(k) clearances
6,581
Adverse events (266 deaths)
1
Recalls
39
Facilities
Description
DXT is intended to be used in blood establishments to facilitate networked communication between DXT compatible Fresenius Kabi apheresis devices and BECS or other Data Management Systems.
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 only. The defect is |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.