Class 2 Device Recall Coaguchek

• Date Initiated by Firm: February 28, 2007
• Date Posted: April 11, 2007
• Recall Status: Terminated on June 13, 2007
• Recall Number: Z-0737-2007
• Recall Event ID: 37602
• 510(K)Number: K930454 K962571 K974569 K994349
• Product Classification: PLASMA, COAGULATION CONTROL , TEST STRIPS - Product Code GJS
• Product: CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
• Code Information: Lots 469A and 475A; exp. 6/30/2008.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46250-0416
• For Additional Information Contact: 800-428-4674
• Manufacturer Reason for Recall: The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
• FDA Determined Cause: Other
• Action: All consignees were notified by telephone on/or about 2/28/07 and some received a follow-up letter dated 3/2/07 or 3/5/07.
• Quantity in Commerce: 10
• Distribution: Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
• 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 = GJS; 510(K)s with Product Code = GJS