# FDA recall Z-0635-2021

> **Helena Laboratories, Corp.** · Class II · device recall initiated 2020-11-09.

## 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.

## Reason for recall

Due to complaints received associated with cracked/split test tube caps.

## 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.

## Key facts

- **Recall number:** Z-0635-2021
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-11-09
- **Report date:** 2020-12-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Beaumont, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2021

## Citation

> AI Analytics. FDA recall Z-0635-2021. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0635-2021. Source: US FDA. Licensed CC0.

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