Helena Laboratories K-ACT Actalyke Test Tubes Recall: Cracked Caps Risk

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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 K-ACT Actalyke Clotting Test Tubes that have cracked or split caps. This could lead to leaks or contamination during blood tests, which might affect test accuracy.

Why it’s dangerous

Cracked or split test tube caps can cause leaks during blood tests. This may lead to inaccurate test results or potential contamination of samples, but does not pose a direct injury risk.

Who’s affected

Users of the ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER and ACTALYKE MINI systems who purchased test tubes with lot numbers 1-19-K-ACT or 2-19-K-ACT are affected. Healthcare professionals and lab technicians using these test tubes are most at risk.

How to tell if you have this one

Check the lot number on the test tube packaging. Affected lots are 1-19-K-ACT and 2-19-K-ACT. The test tubes are used with ACTALYKE XL and ACTALYKE MINI systems.

Brand
Helena Laboratories
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Test Tube Lot Number
Look for the lot number on the test tube packaging. Affected lots are 1-19-K-ACT and 2-19-K-ACT.

✎ GovInfoNow

Questions people ask

Why are these test tubes being recalled?

Due to complaints about cracked or split test tube caps, which could cause leaks or contamination during blood tests.

What should I do if I have these test tubes?

Check the lot number on the test tube packaging. If it's 1-19-K-ACT or 2-19-K-ACT, contact Helena Laboratories for guidance.

Are there any safety risks from cracked caps?

Cracked caps may cause leaks or contamination during blood tests, but do not pose a direct injury risk.

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-0635-2021 — Helena Laboratories Helena Laboratories

Hello,

I own a Helena Laboratories that is covered by recall Z-0635-2021 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-0635-2021 (November 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0635-2021 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 K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE

Lower-risk recall