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U.S. Department of Health and Human Services

Class 2 Device Recall ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below

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  Class 2 Device Recall ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below see related information
Date Initiated by Firm August 15, 2014
Date Posted September 12, 2014
Recall Status1 Terminated 3 on March 04, 2015
Recall Number Z-2637-2014
Recall Event ID 69086
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
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.
Recalling Firm/
Manufacturer		 Data Innovations, LLC
2914 Cleveland Ave
Fort Myers FL 33901-6003
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Data Innovations LLC sent an Important Medical Device Information letter on August 15, 2014, to consignees for the JResultNet using ProVue Instrument Driver JResultNet (provue.jrm) v. 1.5.3 and below. Potential issues with the ProVue driver have been identified which may cause data to be mis-associated with patient results under a given set of circumstances. The user on the ProVue transmits the same results twice back to back by clicking the Send to Host button twice. The ProVue sends two ASTM messages back to back before ending transmission (sending an EOT character) The solution was to disconnect JResultNet from the ProVue instrument and apply the patch to driver provue.jrm when it is available. If you have further questions regarding this notice, please feel free to contact us at northamerica-support@datainnovations.com or 239-931-6004 Toll-Free (from the US and Canada): 1-800-332-0499.
Quantity in Commerce 84
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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