Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont…

Recall date

December 7, 2017

Source

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

Recall number

Z-2761-2019

FDA classification

Class II

Brand / firm

Helena Laboratories, Corp.

Sold / distributed

Distribution was made to Germany and Australia. There was no U.S. distribution.

Why it was recalled

Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.

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, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.