Recall Z-1161-06 ยท MDB System, Blood Culturing
bioMerieux Inc
OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
| Date | Jun 22, 2006 (initiated Mar 28, 2006) |
| Status | Terminated |
| Reason | Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle ID's |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 Netherlands, Germany, Greece, Portugal, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.