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FDADecember 7, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

helena laboratorieshelena

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX. — Recall Details · AllClear