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FDAJanuary 5, 2021device

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.

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

The hazard

Intermittent potential for shorter than expected clot times.

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 - 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. — Recall Details · AllClear