ClearanceBrief
Recall Z-1236-2009 ยท JQP Calculator/Data Processing Module, For Clinical Use

Cerner Corp

Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2.

DateMay 1, 2009 (initiated Jan 19, 2009)
StatusTerminated
ReasonSpecimen labels printing incorrect patient demographics.
Root causeSoftware design
ActionCerner Corporation issued a "Priority Review Flash" dated January 15, 2009 via e-mail to consignees using the software. The letter described the violative nature of the software and explained the proper navigation controls needed to prevent further issues. Further questions should be addressed to Bridge Client Support at 1-800-786-0239.
Quantity4
DistributionNationwide distribution to states of OH, NC, MO and MI.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.