Helena Laboratories, Inc. recalls Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2)…

Recall date

April 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0594-2019

FDA classification

Class II

Brand / firm

Helena Laboratories, Inc.

Sold / distributed

US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.

Why it was recalled

Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

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

What was recalled

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.