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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Safety Alert: BacT/ALERT BacT/VIEW Users

To: Blood Bank and Laboratory Services Supervisors

FDA is informing the healthcare community 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. 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 your bottle results, it can cause a delay in the transmission of these results to your 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.

It is important that the information below be communicated appropriately within your laboratory to increase awareness of:

  1. What happens when a PC database corruption occurs,
  2. Where to find instructions within the User’s Manual that will allow you to troubleshoot the issue,
  3. Actions that may be taken in order to reduce the likelihood that a PC database corruption will occur, and
  4. Actions that may be taken in order to reduce the impact of a database corruption on your laboratory’s ability to get current results from your LIMS/LIS system.

Additional information to help you address this issue can be obtained at http://industry.biomerieux-usa.com/news/pressreleases/bactview_fdaupdate.htm.