Class 2 Device Recall

• Date Initiated by Firm: April 25, 2003
• Date Posted: May 29, 2003
• Recall Status: Terminated on June 19, 2003
• Recall Number: Z-0870-03
• Recall Event ID: 26091
• 510(K)Number: K984105
• Product Classification: Immunoassay Method, Troponin Subunit - Product Code MMI
• Product: Elecsys Troponin T; catalog number 2017644
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Roche Diagnostics Corp.; 9115 Hague Road; Indianapolis IN 46250-0457
• For Additional Information Contact: 800-428-2336
• Manufacturer Reason for Recall: Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
• FDA Determined Cause: Other
• Action: An Urgent Product Correction letter was mailed to each account, during the week of 4/21/03, advising them not to use hemolyzed specimens with a hemoglobin level equal to, or greater than, 0.1 g/dL.
• Distribution: United States
• 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