medical Class II Updated 2019-10-09

Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card, Model 5722, For Export Only.

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Distribution was made to Germany and Australia. There was no U.S. distribution.
Lot/Code Info: Lot number 2-17-5722, Exp. 2018-09-30
View official government recall

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