Recall · FDA
Data Innovations, LLC
Data Innovations, LLC issued a Class II FDA recall (Z-1680-2017) initiated 2014-10-23: JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments a…
| Company | Data Innovations, LLC |
|---|---|
| Recall number | Z-1680-2017 |
| Classification | Class II |
| Status | Terminated |
| Category | Devices |
| Initiated | 2014-10-23 |
| Product | JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information |
| Reason | Software issue resulting in the results of one patient potentially being associated with another. |
FAQ
What did Data Innovations, LLC recall?
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, …
Why was Data Innovations, LLC's product recalled?
Software issue resulting in the results of one patient potentially being associated with another.