Class 2 Device Recall Bac T/ALERT 3D Combination Module

• Date Initiated by Firm: May 27, 2005
• Date Posted: September 07, 2005
• Recall Status: Terminated on September 21, 2006
• Recall Number: Z-0613-05
• Recall Event ID: 32377
• 510(K)Number: K903505
• Product Classification: System, Blood Culturing - Product Code MDB
• Product: Bac T/ALERT 3D Combination Module
• Code Information: All Models
• 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: A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on May 27, 2005.
• Quantity in Commerce: 2,001 units
• Distribution: Nationwide, Argentina, Australia/N. Zealand, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Sweden, Switzerland, 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