The Recall Desk
ModerateFDA (Devices)·Z-0635-2021·Announced 2020-12-23

Helena Laboratories Recalls K-ACT Actalyke Clotting Test Tubes

Helena Laboratories is recalling K-ACT Actalyke Clotting Test Tubes due to complaints of cracked or split caps.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text cites complaints of cracked caps without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Helena Laboratories, Corp. is recalling K-ACT Actalyke Clotting Test Tubes used in the ACTALYKE XL Activated Clotting Time Analyzer and ACTALYKE Mini Activated Clotting Time Test System. The recall is due to complaints received regarding cracked or split test tube caps.

The affected products are identified by Catalog Number K-ACT and Lot Numbers 1-19-K-ACT (314 tubes) and 2-19-K-ACT (297 tubes). These products were distributed worldwide, including nationwide in the United States (specifically noting NJ, NY, PA, and TX) and in Austria, Canada, England, France, Italy, Portugal, Russia, and Spain.

Users of these test tubes should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Manufacturer
Helena Laboratories, Corp.
Category
Medical Device — Laboratory Test Tubes
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Related recalls

Same manufacturer · Helena Laboratories, Corp.

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