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U.S. Department of Health and Human Services

Class 2 Device Recall IM Abbott Alinity ciseries (abdicqii) accessory driver

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  Class 2 Device Recall IM Abbott Alinity ciseries (abdicqii) accessory driver see related information
Date Initiated by Firm August 29, 2018
Create Date October 22, 2018
Recall Status1 Terminated 3 on February 05, 2019
Recall Number Z-0203-2019
Recall Event ID 81005
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
Code Information accessory driver version number 8.00.0001
Recalling Firm/
Manufacturer		 Data Innovations, LLC
120 Kimball Ave Ste 100
South Burlington VT 05403-6837
For Additional Information Contact Customer service
802-658-1955
Manufacturer Reason
for Recall		 Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. This has been determined to be a driver malfunction. When an instrument transmits results from a quality control (QC) sample ID ("Q^Control" in SPM segment), and the option Hold Results Until Complete is enabled, the results do not parse into IM. The communication Trace shows the sample being transmitted, but no information is logged in the Specimen Event Log (SEL). There is a potential for harm if QC results are not processed, downstream auto verification rules may misfire based on missing QC results leading to a delay in, or incorrect treatment. QC results will not be available for evaluation by the lab. There have been no reported instances of patient harm from this malfunction.
FDA Determined
Cause 2		 Software design
Action On August 29, 2018, the firm began notifying affected customers via an Important Medical Device Recall/Field Safety Notice Information letter. The communication advised customers of the issue with Abbott Diagnostics Alinity ci-series (abdicqii) instrument not processing QC results if "Hold Results Until Complete" is enabled. Customers are advised to do the following: 1. Apply the updated v8.00.0002 version of Instrument Manager driver to correct this issue. The updated version is available around September 7, 2018. 2. Use the following workaround: Disable the "Hold Results Until Complete" option in Instrument Manager (driver configuration). If Hold Results Until Complete logic is required, there is no workaround; discontinue use until updated driver is installed. 3. Distribute notification on to anyone in your organization who needs to be aware. 4. Complete the customer response form and return to recalling firm. If you have any questions regarding this recall, please contact Support Email USA: northamerica-support@datainnovations.com, or Support Phone: +1(802) 658-1955.
Quantity in Commerce 9
Distribution Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland.
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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