Recall Z-2637-2014— Data Innovations, LLC
Class II · Terminated
Class II FDA medical device recall by Data Innovations, LLC, initiated 2014-08-15, terminated 2015-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.. Reason: 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..
- Recalling firm
- Data Innovations, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-15
- Terminated
- 2015-03-04
- Firm location
- Fort Myers, FL, United States
Product description
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.