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FDA device recallVulnerabilitiesPublished Oct 30, 2025
Beckman Coulter, Inc.: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Updated under an hour ago ()
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.
- Tags
- FDA recall, medical device, class 1, Clinical Chemistry, Software design, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security
- Source record id
- Z-0412-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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