Lower riskMedical device recall · FDA · Published January 5, 2021
Helena Laboratories Cascade Abrazo aPTT Test Card Recall: Shorter Clot Times Risk
Helena Laboratories recalls Cascade Abrazo aPTT Test Cards (Model 5722) due to intermittent shorter clot times. Affected lots expire by Dec 2021. Contact for replacement.
“Helena Laboratories Cascade Abrazo aPTT Test Card Recall: Shorter Clot Times Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63468-helena-laboratories-cascade-abrazo-aptt-test-card-recall-shorter-clot. Based on FDA recall #Z-1108-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1108-2021%22&limit=1).
Helena Laboratories, Corp. recalled Cascade Abrazo aPTT Test Cards due to the potential for shorter than expected clot times, according to the Food and Drug Administration on Jan. 5, 2021.
How to tell if you have it
Brand: Helena Laboratories
Product: Cascade Abrazo aPTT Test Card
Model Number: 5722
Lot Numbers: 1-20-5722 (expiration date 90/30/2021), 3-20-5722 (expiration date 11/30/2021), 4-20-5722 (expiration date 12/31/2021)
Quantity: 205 total kits
Distribution: U.S. Nationwide, Germany, Italy, Romania, Australia, Chile
The hazard
The recall addresses an intermittent potential for shorter than expected clot times in the test cards.
Context
GovInfoNow's records show Helena Laboratories, Corp. has 8 other recalls on record since July 21, 2017. Other recent recalls of similar products include Helena Serrated Blade Kit May Cause Incorrect Test Results (May 2, 2023), Helena V8 Immunodisplacement Kit Recall: Microbial Growth Causes Interpretation Errors (April 6, 2022), and Helena Laboratories K-ACT Actalyke Test Tubes Recall: Cracked Caps Risk (Nov. 9, 2020). Other recent recalls of similar products include Abiomed Impella CP Set Recall: Risk of Blood Clots During Prolonged Use (May 22, 2026), Abiomed Impella CP Set with SmartAssist: Risk of Blood Clots During Prolonged Use (May 22, 2026), and Abiomed 14 Fr Introducer Kit Recall: Risk of Blood Clots During Prolonged Use (May 22, 2026).
How to tell if you have this one
Look for the model number 5722 on the test card. Check the lot numbers: 1-20-5722 (expires 90/30/2021), 3-20-5722 (expires 11/30/2021), or 4-20-5722 (expires 12/31/2021).
Brand
Helena Laboratories
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Card Lot Number
Look for the lot number on the test card: 1-20-5722, 3-20-5722, or 4-20-5722.
Contact Manufacturer
Reach out to Helena Laboratories for replacement or further instructions.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.9 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1108-2021 (January 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1108-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.