FDA Recall
Terminated
Pathfast D-Dimer, Reference number: PF1051-KUS
Recall: Z-0646-2017
·
Initiated August 16, 2016
Recall
- Recall Number
- Z-0646-2017
- Event Number
- 75511
- Firm
- Lsi Medience Corporation 13-4 Uchikanda
- FEI Number
- 3010736318
- Product Code
- GHH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 16, 2016
- Posted
- November 21, 2016
- Terminated
- February 27, 2017
- Address
- 1 Chome Tokyo Japan
Description
Pathfast D-Dimer, Reference number: PF1051-KUS
Reason
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
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.
Distribution
US Distribution to the states of : AL, FL, ID and MA.
Quantity
42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).