Class 2 Device Recall BacT/ALERT FN Culture Bottles

• Date Initiated by Firm: February 16, 2007
• Date Posted: August 22, 2007
• Recall Status: Terminated on December 08, 2009
• Recall Number: Z-1189-2007
• Recall Event ID: 38433
• 510(K)Number: K992432
• Product Classification: Culture Bottles - Product Code MBD
• Product: BacT/ALERT FN Culture Bottles, Product Number 259793
• Code Information: Product number 259743, Lot 1015145
• Recalling Firm/ Manufacturer: bioMerieux, Inc.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: Brian Brundidge; 919-620-2599
• Manufacturer Reason for Recall: Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.
• FDA Determined Cause: Other
• Action: Consignees were notified by Urgent Product Recall letter on 02/19/2007. They were instructed to destroy any unused inventory of this product lot that they have on hand.
• Quantity in Commerce: 2,403 cases (100 bottles per case)
• Distribution: Worldwide; USA, Austria, Bulgaria, Caledonia, China, Croatia, Curacao, Finland, France, Germany, Greece, Guadeloupe, Italy, Latvia, Mexico, Netherlands, Poland, Portugal, Spain, Saudi Arabia, Sultanate of Oman, Switzerland, Sweden, and United Kingdom
• 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 = MBD