Class 3 Device Recall

• Date Initiated by Firm: September 17, 2004
• Date Posted: February 01, 2005
• Recall Status: Terminated on December 08, 2009
• Recall Number: Z-0456-05
• Recall Event ID: 30261
• 510(K)Number: K903505
• Product Classification: System, Blood Culturing - Product Code MDB
• Product: BacT/ALERT(BTA) Classic instruments.
• Code Information: All codes associated with the product.
• Recalling Firm/ Manufacturer: bioMerieux; 100 Rodolphe St Bldg 1300; Durham NC 27712-9402
• For Additional Information Contact: Jocelyn Jennings; 919-620-2968
• Manufacturer Reason for Recall: Over heating of memory board.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on September 17, 2004.
• Quantity in Commerce: 1626 units
• Distribution: Nationwide, Argentina, Australia, Belgium, Brazil, Canada, Colombia, Denmark, Finland, France, Germany, Greece, India, Indonesia, Italy, Japan, Korea, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Thailand, Turkey, UK.
• 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