Class 2 Device Recall PATHFAST DDimer

• Date Initiated by Firm: August 16, 2016
• Date Posted: November 21, 2016
• Recall Status: Terminated on February 27, 2017
• Recall Number: Z-0646-2017
• Recall Event ID: 75511
• 510(K)Number: K072288
• Product Classification: Fibrin split products - Product Code GHH
• Product: Pathfast D-Dimer, Reference number: PF1051-KUS
• Code Information: Lot T528
• Recalling Firm/ Manufacturer: Lsi Medience Corporation; 13-4 Uchikanda 1 Chome; Tokyo Japan
• For Additional Information Contact: Roger Hanfin; 704-547-6517
• Manufacturer Reason for Recall: Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Customers were notified by letter sent via email on/about August 1, 2016. They were instructed to stop using and destroy the affected kits. They were to perform a retrospective analysis of the patients tested on the batch and investigate further. A Destruction Certificate was attached to be completed and returned to Verbatim Americas, LLC. For further questions please call (704) 547-6517.
• Quantity in Commerce: 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
• Distribution: US Distribution to the states of : AL, FL, ID and MA.
• 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 = GHH