Helena Laboratories Cascade Abrazo aPTT Test Card Recall: Shorter Clot Times Risk

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Contact the company & request your remedy

Recalling firmHelena Laboratories, Corp.1530 Lindbergh Dr, N/A · Beaumont, TX 77707-4131

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Helena Laboratories is recalling Cascade Abrazo aPTT Test Cards (Model 5722) because they may cause shorter than expected clot times. This could lead to inaccurate blood clotting tests, which might affect medical decisions.

Why it’s dangerous

The test cards may produce shorter clot times than intended, leading to inaccurate blood clotting test results. This could cause incorrect medical decisions if the test is used for critical blood clotting assessments.

Who’s affected

Healthcare professionals using the Cascade Abrazo analyzer with these test cards. Patients receiving blood tests may be at risk if the test results are inaccurate.

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.

✎ GovInfoNow

Questions people ask

What is the model number of the recalled test cards?

The model number is 5722.

What lot numbers are affected?

Lot numbers 1-20-5722, 3-20-5722, and 4-20-5722 are affected.

When do these test cards expire?

The test cards expire by December 31, 2021.

Take action

Contact Helena Laboratories

We’ve drafted a message you can send Helena Laboratories to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1108-2021 — Helena Laboratories Helena Laboratories

Hello,

I own a Helena Laboratories that is covered by recall Z-1108-2021 from Helena Laboratories.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-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.

Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the

Lower-risk recall