Class 2 Device Recall

• Date Initiated by Firm: March 28, 2005
• Date Posted: October 28, 2005
• Recall Status: Terminated on April 06, 2006
• Recall Number: Z-0100-06
• Recall Event ID: 31372
• 510(K)Number: K994349
• Product Classification: Test, Time, Prothrombin - Product Code GJS
• Product: Roche CoaguChek S System Controls; Catalog number 3033384, part numbers 010018501 and 04393198001.
• Code Information: All lots.
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-428-4674
• Manufacturer Reason for Recall: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter dated 3/28/05 and were provided new ampoule breakage precautions/ instructions.
• Quantity in Commerce: unknown.
• 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 = GJS