Recall Z-0203-2019 ยท JQP Calculator/Data Processing Module, For Clinical Use
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]).
| Date | Aug 29, 2018 |
| Status | Terminated |
| 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 miss |
| 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" o |
| Quantity | 9 |
| Distribution | Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.