Device 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.
Z-2637-2014
Product summary
- Event
- Event 69086
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84
- Official record key
device-enforcement:Z-2637-2014
Official wording
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.
Code information: Version #s: 1.0.0 Date Released 6/17/2004, 1.0.1 Date Released 8/18/2004, 1.1.1 Date Released 9/9/2004, 1.2.0 Date Released 10/11/2004, 1.3.0 Date Released 11/1/2004, 1.3.1 Date Released 1/20/2005, 1.3.2 Date Released 2/18/2005, 1.4.0 Date Released 3/30/2005, 1.4.1 Date Released 8/31/2005, 1.4.2 Date Released 9/12/2005, 1.4.2 Date Released 10/5/2005, 1.4.3 Date Released 2/8/2006, 1.4.4 Date Released 2/20/2006, 1.4.5 Date Released 3/3/2006, 1.4.5 Date Released 3/23/2006, 1.4.5 Date Released 5/17/2006, 1.5.0 Date Released 6/26/2007, 1.5.1 Date Released 9/17/2007, 1.5.1 Date Released 12/13/2007, 1.5.1 Date Released 11/7/2008, 1.5.2 Date Released 4/13/2009, 1.5.3 Date Released 1/12/2011.
Distribution pattern: Nationwide Distribution including AL, AZ, CA, CT, DC, FL, GA, IN, LA, MI, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA.
Derived failure modes
-
Unknown
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.