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Data Innovations Recalls
4 recalls on record · January 1, 2014 to October 31, 2018 · Medical Devices
Recalls by year
14
17
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 31, 2018Medical DevicesFDA
Data Innovations, LLC recalls IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a
Hazard: 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.
April 5, 2017Medical DevicesFDA
Data Innovations, LLC recalls JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone softwa
Hazard: Software issue resulting in the results of one patient potentially being associated with another.
September 24, 2014Medical DevicesFDA
Data Innovations, LLC recalls ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package
Hazard: Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.
January 1, 2014Medical DevicesFDA
Data Innovations, Inc. recalls Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior t
Hazard: When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option "Strip Zeros from Result" set to "Yes" may result in sample error