Z-0646-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 30, 2016
- Initiation Date
- August 16, 2016
- Termination Date
- February 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
Product Description
Pathfast D-Dimer, Reference number: PF1051-KUS
Reason for Recall
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Distribution Pattern
US Distribution to the states of : AL, FL, ID and MA.
Code Information
Lot T528