Class 2 Device Recall CoaguChek test strips

• Date Initiated by Firm: February 20, 2003
• Date Posted: April 10, 2003
• Recall Status: Terminated on November 10, 2003
• Recall Number: Z-0720-03
• Recall Event ID: 25795
• 510(K)Number: K974569
• Product Classification: System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
• Product: CoaguChek PT test strips, sold in 12 pack.
• Code Information: lot 533
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Road; Indianapolis IN 46250-0457
• Manufacturer Reason for Recall: Discrepancy between INR and the % Quick displayed on the meter.
• FDA Determined Cause: Other
• Action: Customers in Germany were notified of the recall, and asked to return this lot of product. While the product is sold in many countries, Germany is the only country affected, since their results are the only ones reported as % Quick.
• Quantity in Commerce: 11412 containers
• Distribution: Germany
• 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 = JPA and Original Applicant = BOEHRINGER MANNHEIM CORP.