Class 2 Device Recall Advanced DDimer

• Date Initiated by Firm: July 29, 2005
• Date Posted: November 18, 2005
• Recall Status: Terminated on March 01, 2006
• Recall Number: Z-0172-06
• Recall Event ID: 32887
• 510(K)Number: K041438
• Product Classification: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
• Product: Advanced D-Dimer used with the Sysmex CA-1500, CA-7000, CA-500 Systems when using the AKIMA method.
• Code Information: Catalog number OQWM
• Recalling Firm/ Manufacturer: Dade Behring , Inc.; 500 GBC Dr., Mailstop 514; PO BOX 6101; Newark DE 19714-6101
• For Additional Information Contact: Aydee Crawford; 302-631-6312
• Manufacturer Reason for Recall: Reports of false negative results on Sysmex Coagulation System.
• FDA Determined Cause: Other
• Action: On 7/29/05, the recalling firm issued a recall letter to their accounts informing them of the probelm. The letter also provided instruction on how to prevent the probelm from occurring - change from the AKIMA method to the Point ot Point method.
• Quantity in Commerce: 2987 units
• Distribution: The product was shipped to medical facilities 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 = DAP and Original Applicant = DADE BEHRING, INC.