Device product
Pathfast D-Dimer, Reference number: PF1051-KUS
Z-0646-2017
Product summary
- Event
- Event 75511
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
- Official record key
device-enforcement:Z-0646-2017
Official wording
Reason: Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Code information: Lot T528
Distribution pattern: US Distribution to the states of : AL, FL, ID and MA.
Derived failure modes
-
Unknown
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.