FDA Device recall Z-0203-2019
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer s…
- FDA Device
- Class II
- terminated
- Published 2018-10-31
On 2018-10-31 the FDA classified a Class II recall of IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer s… by Data Innovations, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0203-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-29 |
| Published | 2018-10-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Data Innovations |
| Distribution | OK |
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]).
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.
Identifiers
| code_info | accessory driver version number 8.00.0001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0203-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.