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Lsi Medience Corporation recalls Pathfast D-Dimer, Reference number: PF1051-KUS
Recalled November 30, 2016 · FDA recall Z-0646-2017 · Lsi Medience
Hazard
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product. · FDA Class II
Units
42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
Sold at
US Distribution to the states of : AL, FL, ID and MA.
Description
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Product
Pathfast D-Dimer, Reference number: PF1051-KUS
Manufacturer(s)
Lsi Medience Corporation
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →