Recall Z-0646-2017
Lsi Medience Corporation · initiated August 16, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Pathfast D-Dimer, Reference number: PF1051-KUS
Codes / lots: Lot T528
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 taken
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.
Details
- Recall number
- Z-0646-2017
- Initiated
- August 16, 2016
- Posted by FDA
- November 21, 2016
- Terminated
- February 27, 2017
- Product code
- GHH – Fibrin Split Products
- Quantity
- 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.
- Recalling firm
- Lsi Medience Corporation, Tokyo, 1 Chome