OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
FDA device recall Z-1161-06 · posted 2006-06-22 · Terminated
Recall details
- Recalling firm
- bioMerieux Inc
- Reason for recall
- Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MDB
- Quantity affected
- 51 units
- Distribution
- WorldwideDistribution--Nationwide to medical centers. Government distribution was made to MN and CA, and military distribution was made to OK. Foreign distribution was made to Thailand, The Netherland
- Date initiated
- 2006-03-28
- Date posted
- 2006-06-22
- Date terminated
- 2008-03-07
- Location
- Hazelwood, MO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.