Lsi Medience Corporation: Medical Device Recall in 2016 - (Recall #: Z-0646-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Pathfast D-Dimer, Reference number: PF1051-KUS

Product Classification:

Class II

Date Initiated: August 16, 2016

Date Posted: November 30, 2016

Recall Number: Z-0646-2017

Event ID: 75511

Reason for Recall:

Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product.

Status: Terminated

Product Quantity: 42 boxes (each containing 60 test cartridges/one kit contains 10 reagent cartridge trays and one tray has 6 cartridges).

Code Information:

Lot T528

Distribution Pattern:

US Distribution to the states of : AL, FL, ID and MA.

Voluntary or Mandated:

Voluntary: Firm initiated