Nuclein LLC: Instrumentation For Clinical Multiplex Test Systems

Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).

Tags

FDA recall, medical device, class 2, Clinical Chemistry, Process control, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security; CISM 3: Information Security Program

Source record id

Z-2861-2026

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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