Class 2 Device Recall BacT/VIEW C.30a Software update (P/N 5145151)

• Date Initiated by Firm: December 19, 2006
• Date Posted: March 22, 2007
• Recall Status: Terminated on December 08, 2009
• Recall Number: Z-0644-2007
• Recall Event ID: 37141
• 510(K)Number: K903505 K934593 K954468 K981736
• Product Classification: diagnostic data management system - Product Code MDB
• 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
• Code Information: All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).
• Recalling Firm/ Manufacturer: bioMerieux, Inc.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: Brian Brundidge; 919-620-2968
• Manufacturer Reason for Recall: Bottle data is not sent to BacT/ALERT 3D instrument.
• FDA Determined Cause: Other
• Action: A customer notification advising customers of the issues and the precautions were sent on/about December 20, 2006.
• Quantity in Commerce: 1233 disks
• Distribution: Worldwide, including USA, Canada, UK, Italy, France, Spain, Germany, Poland, Chile, Japan and the Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MDB