Data Innovations recalls IM Abbott Alinity ci-series software v8.00.0001 that may cause quality control results to not process, potentially delaying or misdirecting patient treatment. No patient harm has been reported.
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.
Data Innovations is recalling a software update for Abbott Alinity ci-series instruments that may cause quality control results to not process properly. This could lead to delayed or incorrect patient treatment if the software fails to handle QC samples correctly.
The software may not process quality control samples correctly, causing lab results to not appear in the system. This could lead to delayed or incorrect patient treatment if the software fails to handle QC samples properly.
Healthcare facilities using the specific software version for Abbott Alinity ci-series instruments. Staff handling lab results are most at risk if the software malfunction affects patient care.
The software version number 8.00.0001 for IM Abbott Alinity ci-series (abdicqii) instruments. This software is used with hospital computer systems for lab information.
Verify the software version on your Abbott Alinity ci-series instrument to see if it is 8.00.0001.
The software malfunction may cause quality control results to not process, but no patient harm has been reported.
If quality control results are not processed, downstream auto verification rules may misfire, potentially delaying or incorrect treatment.
The official recall does not specify a remedy, so check with your healthcare provider or Abbott for guidance.
We’ve drafted a message you can send Data Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-0203-2019 — Data Innovations Data Innovations Hello, I own a Data Innovations that is covered by recall Z-0203-2019 from Data Innovations. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
