Lower riskMedical device recall · FDA · Published November 9, 2020
Helena Laboratories K-ACT Actalyke Test Tubes Recall: Cracked Caps Risk
Helena Laboratories recalls K-ACT Actaly: Cracked test tube caps may cause leaks or contamination during blood tests. Affected lots 1-19-K-ACT and 2-19-K-ACT.
“Helena Laboratories K-ACT Actalyke Test Tubes Recall: Cracked Caps Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63956-helena-laboratories-k-act-actalyke-test-tubes-recall-cracked-caps. Based on FDA recall #Z-0635-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0635-2021%22&limit=1).
Helena Laboratories, Corp. recalled K-ACT Actalyke Clotting Test Tubes due to cracked or split caps, the FDA said on Nov. 9, 2020. The voluntary Class II recall affects tubes distributed worldwide.
How to tell if you have it
Brand: Helena Laboratories
Product: K-ACT Actalyke Clotting Test Tubes
Catalog Number: K-ACT
Lot Numbers: 1-19-K-ACT, 2-19-K-ACT
The hazard
The recall addresses complaints associated with cracked or split test tube caps. The record does not report specific incidents or injuries.
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 Cascade Abrazo aPTT Test Card Recall: Shorter Clot Times Risk (Jan. 5, 2021).
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.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 4 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New Jersey, New York, Pennsylvania, Texas.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-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.