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.
FDA Recall Z-2637-2014 · Posted 2014-09-12
Recalling FirmData Innovations, LLC
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-08-15
Date Terminated2015-03-04
Product Quantity84
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.
Firm 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 [email protected] or 239-931-6004 Toll-Free (from the US and Canada): 1-800-332-0499.
Root Cause
Software design
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.