—#49971

Product

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

FDA product code: MDB — System, Blood Culturing
Device class: Class 1
Medical specialty: Microbiology
510(k) numbers: K903505, K934593, K954468, K981736
Affected lot / code info: All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).

Why it was recalled

Bottle data is not sent to BacT/ALERT 3D instrument.

Root cause (FDA determination)

Other

Action the firm took

A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.

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: 2007-03-22
Terminated: 2009-12-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.