Separator, Automated, Blood Cell, Diagnostic
FDA adverse event reports and recall history for separator, automated, blood cell, diagnostic (product code GKT), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 6,565
- Deaths
- 264
- Injuries
- 930
- Malfunctions
- 5,069
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- TerminatedUnder Investigation by firm
Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells.
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 a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
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