Medical device recalls Moderate risk

Lsi Medience Corporation recalls Pathfast D-Dimer, Reference number: PF1051-KUS

Recall date
August 16, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0646-2017
FDA classification
Class II
Brand / firm
Lsi Medience Corporation
Sold / distributed
US Distribution to the states of : AL, FL, ID and MA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pathfast D-Dimer, Reference number: PF1051-KUS

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