Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pathfast D-Dimer Recalled by Lsi Medience Corporation Due to Two complaints were received about decrease in sensitivity...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Lsi Medience Corporation directly.
Affected Products
Pathfast D-Dimer, Reference number: PF1051-KUS
Quantity: 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).
Why Was This Recalled?
Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.
Where Was This Sold?
This product was distributed to 4 states: AL, FL, ID, MA
About Lsi Medience Corporation
Lsi Medience Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report