Fast-breaking News from AABB PulsePoints The following has been reproduced from the December 23, 2005 AABB PulsePoints, an electronic news alert provided by the American Association of Blood Banks.

Dec. 23, 2005
No. 729

CBER Issues Important Safety Alert for BacT/ALERT^® BacT/VIEW^® Users

AABB PulsePoints

The Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), on Dec. 16, 2005, published a notice alerting blood bank and laboratory services supervisors "of a database corruption situation that may lead to a failure to report positive cultures or cause a delay in appropriate patient therapy when using the BacT/VIEW^® data management feature of Biomerieux's BacT/ALERT^® system."

According to the safety alert, "Database corruptions can interrupt communication between the BacT/VIEW^® computer and a site’s laboratory information management system/laboratory information system (LIMS/LIS)." While this type of corruption will not impact the accuracy of one's bottle results, it can cause a delay in the transmission of these results to a site's LIMS/LIS system.

Awareness and understanding of this issue is important for laboratories who:

1. Provide patient testing and blood component bacterial testing services to blood banks and/or hospital blood transfusion services and,
2. Rely solely upon their LIMS/LIS system for notification of positive bottle results.

To view CBER’s alert in its entirety, visit: http://www.fda.gov/cber/safety/bactbio121605.htm.

For additional information, visit:
http://industry.biomerieux-usa.com/news/pressreleases/bactview_fdaupdate.htm.