Notification of BacT/VIEW C.30a Software Update

DATE NOTIFICATION INITIATED:

December 20, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Software Name: BacT/VIEW C.30a Software Update

Affected Instrument Platform: All BacT/ALERT 3D instruments

MANUFACTURER:

bioMerieux, Inc.
Durham, North Carolina

REASON:

bioMerieux, Inc. issued an 'Urgent Product Corrective Action Alert" in which they identified an issue with the BacT/VIEW C.30a software update, causing the BacT/VIEW software to not send supplementary information about BacT/ALERT bottles to the BacT/ALERT 3D instrument. The supplementary bottle information that will not be sent to the BacT/ALERT instrument when it is entered or changed includes: accession number, bottle type, maximum test time, and bottle status. This could result in a bottle being unloaded and discarded before an organism grows sufficiently to be detected by the instrument. This software issue affects BacT/ALERT 3D instrument configurations only. This defect occurs in BacT/VIEW version C.30a only.

A correction to BacT/VIEW C.30a software is in development and will be available in early 2007. Until the new software is available, bioMerieux requests customers who have not installed the C.30a software, not to do so. Customers who have already installed the C.30a software, should follow C.30a 'Workaround Instructions'.

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.