Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cascade Abrazo aPTT Test Card Recalled by Helena Laboratories, Corp. Due to Some of the cards show occasional shorter clot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Helena Laboratories, Corp. directly.
Affected Products
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Quantity: 21 kits
Why Was This Recalled?
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Where Was This Sold?
Distribution was made to Germany and Australia. There was no U.S. distribution.
About Helena Laboratories, Corp.
Helena Laboratories, Corp. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report