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U.S. Department of Health and Human Services

Class 2 Device Recall PATHFAST DDimer

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  Class 2 Device Recall PATHFAST DDimer see related information
Date Initiated by Firm August 16, 2016
Date Posted November 21, 2016
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MITSUBISHI KAGAKU IATRON
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