Class 2 Device Recall Advanced DDimer

• Date Initiated by Firm: December 03, 2004
• Date Posted: February 15, 2005
• Recall Status: Terminated on October 18, 2005
• Recall Number: Z-0538-05
• Recall Event ID: 30634
• 510(K)Number: K041438
• Product Classification: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control - Product Code DAP
• Product: Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.
• Code Information: Lot numbers 544531 to 544548 and 544502 to 544504.
• FEI Number: 2517506
• Recalling Firm/ Manufacturer: Dade Behring , Inc.; Rte 896, Glasgow Business Community; Newark DE 19702
• For Additional Information Contact: Donna Wolf; 302-631-0384
• Manufacturer Reason for Recall: decrease in product stability after reconstitution and reduced stability on board certain instrument systems
• FDA Determined Cause: Other
• Action: The recalling firm issued a recall letter to their customers informing them of the problem and the need to use internal quality controls with the analyzers. The letter instructed customer to discard lot # 544545 and reduce the stability for the other lot numbers involved.
• Quantity in Commerce: 25381 units
• Distribution: The product was shipped nationwide to medical facilities.
• 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