Z-0203-2019Class II

IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive...

Name: Z-0203-2019 IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive...
Creator: Data Innovations, LLC
Published: 2018-08-29
License: https://open.fda.gov/license/

Data Innovations, LLC / initiated 2018-08-29 / Terminated / root cause: software

FDA source

Data Innovations, LLC began a recall of 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... on 2018-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0203-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-29
Posted: 2018-10-22
Terminated: 2019-02-05
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]).
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA 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: [email protected], 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.
Product codes and lots: accessory driver version number 8.00.0001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0203-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0203-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-22

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)