Class II — Potential Health Hazard

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...

Date: August 16, 2016
Company: Lsi Medience Corporation
Status: Terminated
Source: FDA (Device)

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

Affected (4 states)Not affected

About Lsi Medience Corporation

Lsi Medience Corporation has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report