Helena Laboratories Cascade Abraz: False Negative Risk in Export Test Cards
Helena Laboratories recalls export-only Cascade Abrazo aPTT Test Card Model 5722 due to potential false negatives from shorter clot times. Affected units sold with lot 2-17-5722 expiring 2018-09-30.
Lower-risk recall
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Contact the company
What happened, in plain English
Helena Laboratories is recalling export-only Cascade Abrazo aPTT Test Card Model 5722 because some cards may show shorter clot times than expected, causing false negative results in screening tests. This could lead to incorrect health assessments if used without proper follow-up. Read more at govinfonow.com/recall/72375-helena-laboratories-cascade-abraz-false-negative-risk-in-export-test.
Source Summary by GovInfoNow · govinfonow.com/recall/72375-helena-laboratories-cascade-abraz-false-negative-risk-in-export-test · Updated August 31, 2026 · FDA enforcement record: FDA #Z-2761-2019
Cite this page
“Helena Laboratories Cascade Abraz: False Negative Risk in Export Test Cards.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72375-helena-laboratories-cascade-abraz-false-negative-risk-in-export-test. Based on FDA recall #Z-2761-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2761-2019%22&limit=1).
Why it’s dangerous
The test cards may produce shorter clot times than expected, which can cause false negative results in screening assays. This means the test might incorrectly indicate that a blood sample is safe when it isn't, potentially leading to missed health issues.
Who’s affected
Users of the export-only Cascade Abrazo aPTT Test Card Model 5722 for international medical testing. Those with the specific lot number 2-17-5722 are most at risk of false negative results.
How to tell if you have this one
Check for the model number 5722 on the label. The product was sold for export only with lot number 2-17-5722, expiring September 30, 2018.
- Brand
Helena Laboratories- Category
Medical device
What to do — step by step
Check Product Label
Look for the model number 5722 and lot number 2-17-5722 on the label.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2761-2019 (December 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2761-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 31, 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.