ClearanceBrief
Recall Z-0644-2007 ยท MDB System, Blood Culturing

bioMerieux, Inc.

BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, bioMerieux, Inc., P. O. Box 15969, Durham, NC 27704-0969 USA

DateMar 22, 2007 (initiated Dec 19, 2006)
StatusTerminated
ReasonBottle data is not sent to BacT/ALERT 3D instrument.
Root causeOther
ActionA customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.
Quantity1233 disks
DistributionWorldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K903505BACT/ALERT (TM)
Organon Teknika Corp., Mar 12, 1991
K934593BACT/ALERT 120
Organon Teknika Corp., Feb 9, 1994
K954468MB/BACT MYCROBACTERIA DETECTION SYSTEM
Organon Teknika Corp., Jul 22, 1996
K981736BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
Organon Teknika Corp., Jul 24, 1998