Recall – Immunoassay analysis system software error under certain conditions

Company: Abbott Gmbh & Co. KG
Date of Enforcement Report: 9/4/2019
Class II

PRODUCT

Alinity ci -series System Control Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining one or more sample processing modules, in multiple configurations, with a system control module to form a single workstation. The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

  • Recall Number: Z-2363-2019

REASON

Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software where incorrect results may occur after a system Stop due to the Alinity i re use of reaction vessels (RVs). This issue only occurs if the system is transitioned from Processing to Stopped to Idle.

RECALLING FIRM/MANUFACTURER

Abbott Gmbh & Co. KG on 6/10/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1763 units

DISTRIBUTION

US Nationwide and International

Software Verification

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