Recall Z-1680-2017— Data Innovations, LLC
Class II · Terminated
Class II FDA medical device recall by Data Innovations, LLC, initiated 2014-10-23, terminated 2019-08-21. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Data Innovations, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-23
- Terminated
- 2019-08-21
- Firm location
- South Burlington, VT, United States
Product description
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 for recall
Software issue resulting in the results of one patient potentially being associated with another.
Data sourced from openFDA. This site is unofficial and independent of the FDA.