FDAFDA · Food and drugs·Recall number Z-2637-2014
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.
Published September 24, 2014 · Recall initiated: August 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Data Innovations, LLC
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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