Beckman Coulter, Inc.: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

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

9/23/2026

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