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

9/23/2026

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.