Recall – Software issue prevents maintenance procedure

Company: Abbott Molecular, Inc.
Date of Enforcement Report: 12/12/2021
Class II

PRODUCT

Alinity m System, Part No. 08N53-002

Recall Number: Z-0461-2022

REASON

There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure.

RECALLING FIRM/MANUFACTURER

Abbott Molecular, Inc. on 12/6/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

742 devices

DISTRIBUTION

U.S. Nationwide and International

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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