Home / Recalls / Helena Laboratories, Corp. / Z-2761-2019

Z-2761-2019 Class II Terminated

Recalled by Helena Laboratories, Corp. — Beaumont, TX

Recall Details

Product Type: Devices
Report Date: October 9, 2019
Initiation Date: December 7, 2017
Termination Date: June 9, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21 kits

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.

Distribution Pattern

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

Code Information

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

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