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

FDA Recall #Z-2761-2019 — Class II — December 7, 2017

Recall #Z-2761-2019 Date: December 7, 2017 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Helena Laboratories, Corp. — Beaumont, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

21 kits

Distribution

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

Code Information

Lot number 2-17-5722, Exp. 2018-09-30

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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