Class 3 Device Recall Pathromtin SL.

• Date Initiated by Firm: March 01, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on August 19, 2004
• Recall Number: Z-0773-04
• Recall Event ID: 28607
• 510(K)Number: K955450
• Product Classification: Activated Partial Thromboplastin - Product Code GFO
• Product: Pathromtin SL. Partial Thromboplastin Time Tests. The product is sold in kits containing 10 and 20 vials
• Code Information: Lot numbers 523785, 523785A, 523785B, and 523787
• FEI Number: 2517506
• Recalling Firm/ Manufacturer: Dade Behring , Inc.; Rte 896, Glasgow Business Community; Newark DE 19702
• For Additional Information Contact: Donna A. Wolf; 302-631-0384
• Manufacturer Reason for Recall: cloudy appearance or precipitate
• FDA Determined Cause: Other
• Action: The recalling firm issued recall letters dated 3/4/04 to their direct accounts informing them of the problem and what to do if a vial is found to be cloudy.
• Quantity in Commerce: 77886 vials
• Distribution: The products were shipped to one diagnostic facility in PA. The products were also shipped to Germany, Poland, Spain, France, Italy, Portugal, Mexico, Thailand, and Uruguay.
• 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 = GFO