Drug recall
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use…
FDA recall event 76036 · Class II · Data Innovations, LLC
Key facts
| Event ID | 76036 |
|---|---|
| Recall numbers | Z-1680-2017 |
| Recalling firm | Data Innovations, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Software issue resulting in the results of one patient potentially being associated with another. |
| Initiation date | Oct 23, 2014 |
| Report date | Apr 5, 2017 |
| Termination date | Aug 21, 2019 |
| City | South Burlington |
| State | VT |
| Country | United States |
| FEI number | 3001451449 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: