Class 2 Device Recall Elecsys

• Date Initiated by Firm: January 31, 2006
• Date Posted: February 09, 2006
• Recall Status: Terminated on April 10, 2006
• Recall Number: Z-0512-06
• Recall Event ID: 34491
• 510(K)Number: K040733 K051752 K984105
• Product Classification: Immunoassay Method, Troponin Subunit - Product Code MMI
• Product: Roche brand Elecsys Troponin T; catalog number 2017644.
• Code Information: Lot 171924-02.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: 800-428-2336
• Manufacturer Reason for Recall: A false negative result may be reported.
• FDA Determined Cause: Other
• Action: Recall letter dated 1/31/06 was issued to each customer instructing them to stop using, and to discard, the product.
• Quantity in Commerce: 3116 kits
• 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 = MMI; 510(K)s with Product Code = MMI; 510(K)s with Product Code = MMI