Recall – Automated immunoassay analyzer software may not detect issue

Company: Abbott Gmbh & Co. KG
Date of Enforcement Report: 8/14/2019
Class II

PRODUCT

The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,”* * *Alinity ci-series* * *SYSTEM CONTROL MODULE 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. The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).

Recall Number: B-0801-2019

REASON

All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip Technology (ICT) assays, sodium (Na+), potassium (K+), and chloride (Cl-).

RECALLING FIRM/MANUFACTURER

Abbott Gmbh & Co. KG on 5/21/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

943 systems

DISTRIBUTION

US Nationwide and International

Software Verification

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