Data Innovations, LLC: Medical Device Recall in 2018 - (Recall #: Z-0203-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 29, 2018

Date Posted: October 31, 2018

Recall Number: Z-0203-2019

Event ID: 81005

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.

Status: Terminated

Product Quantity: 9

Code Information:

accessory driver version number 8.00.0001

Distribution Pattern:

Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated