Class 2 Device Recall BreathTek

• Date Initiated by Firm: May 02, 2007
• Date Posted: October 04, 2007
• Recall Status: Terminated on November 26, 2007
• Recall Number: Z-0003-2008
• Recall Event ID: 38430
• 510(K)Number: K014225
• Product Classification: in vitro diagnostic software - Product Code MSQ
• Product: BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5 - January 1,'03, in vitro diagnostic. Meretek Diagnostics, Inc., Lafayette, CO.
• Code Information: Version 1.3.5 - January 1, '03
• Recalling Firm/ Manufacturer: Meretek Diagnostics, Inc.; 2655 Crescent Drive, Suite C; Lafayette CO 80026
• For Additional Information Contact: Juli Marki; 720-479-6409
• Manufacturer Reason for Recall: Diagnostic test kit for Helicobacter pylori was distributed for adult and pediatric use, but was not approved for pediatric use.
• FDA Determined Cause: Labeling False and Misleading
• Action: Customers were notified by letter on 05/02/2007 and asked to remove the software program from any computers on which it had been installed and return the software disc and User's Guide to Meretek.
• Quantity in Commerce: 92 units
• Distribution: Nationwide.
• 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 = MSQ