FDA-Device2019-10-09Class II
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Helena Laboratories, Corp.
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.
Sold states
Distribution was made to Germany and Australia. There was no U.S. distribution.
Affected count
21 kits
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2761-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief