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U.S. Department of Health and Human Services

Class 2 Device Recall Alinity ciseries System Control Module

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  Class 2 Device Recall Alinity ciseries System Control Module see related information
Date Initiated by Firm June 10, 2019
Create Date August 24, 2019
Recall Status1 Terminated 3 on June 14, 2023
Recall Number Z-2363-2019
Recall Event ID 83235
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Abbott Gmbh & Co. KG
Max-Planck-Ring 2
65205
Wiesbaden Germany
For Additional Information Contact Albert Chianello
224-668-1923
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software in the Use Environment
Action Abbott sent an Urgent Product Correction Notice by letter dated 06/10/2019. The letter identified the affected product, problem and actions to be taken. Abbott has identified an issue with all onmarket versions of Alinity ciseries Software where reuse of reaction vessels (RVs) may occur after a system Stop. This issue only occurs if the system is transitioned from Processing to Stopped to Idle and has the potential to cause incorrect results.The letter provided a mitigation strategy for the consignee to use until the updated software is available. For questions U.S. Customers contact Customer Service at 18774ABBOTT (available 24 hours a day, 7 days a week). Customers outside the U.S., please contact your local area Customer Service.
Quantity in Commerce 1763 units
Distribution Worldwide Distribution - US Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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