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Recall Observatory FDA recall evidence

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

August 15, 2014

Class II

Product summary

Firm
Data Innovations, LLC
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

    reason.no_named_rule · v1.0.0

    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.