bioMerieux Inc OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
Brand
bioMerieux Inc
Lot Codes / Batch Numbers
Software version R.02.00.17
Products Sold
Software version R.02.00.17
bioMerieux Inc is recalling OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected due to Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's
Recommended Action
Per FDA guidance
The recalling firm telephoned customers who ordered the MB bottles and use the OBSERVA software ver. 2.0 to inform them of the issues. Recall letters were issued to all customers via overnight mail on 5/22/06 informing them a field representative would be visiting to make a short-term correction to the system. The letter also informed the customer a permanent correction to the software was scheduled for release later in the year.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026