—#49959

Product

BacT/VIEW Software, all versions. in vitro diagnostic database software.

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Product Numbers: Software Version C.30a -22105-68, Update Disk; 22105-69 Install Disk

Why it was recalled

BacT/VIEW will be unable to run scheduled macro applications unless the user touches the BacT/VIEW touch screen or clicks a function after resynchronizing the clocks.

Root cause (FDA determination)

Other

Action the firm took

A customer notification was sent on/about December 19, 2006. Customers will be sent a new BacT/VIEW software version C.30b QTR 1 2007.

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.

Timeline

Recall initiated: 2006-12-19
Posted by FDA: 2007-05-18
Terminated: 2009-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49959. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.