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Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont
Recalled October 9, 2019 · FDA recall Z-2761-2019 · Helena Laboratories
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. · FDA Class II
Units
21 kits
Sold at
Distribution was made to Germany and Australia. There was no U.S. distribution.
Description
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Product
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Manufacturer(s)
Helena Laboratories, Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →