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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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

DATE NOTIFICATION INITIATED:

December 19, 2006

PRODUCT / LOT NUMBER / EXPIRATION DATE:

BacT/VIEW Software (all versions)

Product Number:

22105-68 Update Disk
22105-69 Install Disk

 

Affected Platform: BacT/ALERT Classic Instruments

MANUFACTURER:

bioMerieux, Inc.
Durham, North Carolina

REASON:

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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448