Recall – Immunoassay analyzer design defect can lead to overpressure

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 8/18/2021
Class II

PRODUCT

Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.

Recall Number: Z-2241-2021

REASON

A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.

RECALLING FIRM/MANUFACTURER

Abbott Laboratories, Inc on 7/12/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

260 systems

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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