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Vaccines, Blood & Biologics

Notification of BacT/VIEW Software (all versions)-bioMerieux, Inc.


December 19, 2006


BacT/VIEW Software (all versions)

Product Number:

22105-68 Update Disk
22105-69 Install Disk


Affected Platform: BacT/ALERT Classic Instruments


bioMerieux, Inc.
Durham, North Carolina


bioMerieux, Inc. is initiating a 'Voluntary Field Corrective Action' of the BacT/VIEW Software when used in conjunction with the BacT/ALERT Classic Instruments. The BacT/ALERT Classic instrument is designed to generate an error message if the clocks in the Instrument and the BacT/VIEW desynchronize by more than five minutes. When this occurs, the system suspends all activity and requires the operator to enter the correct date and time before activities can resume. The computer and all enabled data unit clocks are then resynchronized to the time and date entered by the operator.

bioMerieux has recently discovered that the BacT/VIEW will be unable to send new test results to an LIS, perform automatic backups or daily reboots, or run scheduled reports, unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/27/2013
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