FDA-Device2016-11-30Class II
Pathfast D-Dimer, Reference number: PF1051-KUS
Lsi Medience Corporation
Hazard
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Sold states
US Distribution to the states of : AL, FL, ID and MA.
Affected count
42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
Manufactured in
13-4 Uchikanda 1 Chome, N/A, Tokyo, N/A, Japan
Products
Pathfast D-Dimer, Reference number: PF1051-KUS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0646-2017Don't want to check this manually?
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