Class 2 Device Recall BacT/ALERT FA Culture Bottles.

• Date Initiated by Firm: January 11, 2007
• Date Posted: March 22, 2007
• Recall Status: Terminated on December 08, 2009
• Recall Number: Z-0643-2007
• Recall Event ID: 37133
• 510(K)Number: K020813
• Product Classification: Culture Bottles - Product Code MDB
• Product: BacT/ALERT FA Culture Bottles, 30 ml, for in vitro diagnostic use, BioMerieux, Inc., Durham, NC 27704
• Code Information: Lot 1014768
• FEI Number: 3002769706
• Recalling Firm/ Manufacturer: bioMerieux, Inc.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: John Cusack, Sr.; 919-620-2803
• Manufacturer Reason for Recall: Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on/about 01/12/2007.
• Quantity in Commerce: 2136 cases (100 bottles per case)
• Distribution: Worldwide, including USA, Austria, Denmark, Finland, France, Greece, Guyana, Italy, Libya, Netherlands, Norway, New Caledonia, Poland, Portugal, Singapore, Slovenia, Spain, Tanzania, and Sweden.
• 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