ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package tha

FDA device recall Z-2637-2014 · posted 2014-09-12 · Terminated

Recall details

Recalling firm

Data Innovations, LLC

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

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.

Date initiated

2014-08-15

Date posted

2014-09-12

Date terminated

2015-03-04

Location

Fort Myers, FL