Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the…

Recall date

January 5, 2021

Source

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

Recall number

Z-1108-2021

FDA classification

Class II

Brand / firm

Helena Laboratories, Corp.

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.

Why it was recalled

Intermittent potential for shorter than expected clot times.

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 aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.