Beckman Coulter Biomedical GmbH: Calculator/Data Processing Module, For Clinical Use

Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.

Tags

FDA recall, medical device, class 1, Clinical Chemistry, Under Investigation by firm, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security

Source record id

Z-2834-2026

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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