FDA Medical Device Recalls (openFDA)
Data Innovations, LLC: 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]).
- Recall number
- Z-0203-2019
- Recalling firm
- Data Innovations, LLC
- 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]).
- Status
- Terminated
- Initiated
- 2018-08-29
- Posted
- not on file
- Terminated
- 2019-02-05
- Reason
- 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.
- Root cause
- 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
- 9
- Distribution
- Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland.
- Lot, serial or model codes
- accessory driver version number 8.00.0001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3001451449
- Firm city
- South Burlington
- Firm state
- VT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28