Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

K-ACT Actalyke Clotting Test Tubes that are used in the: Recalled by Helena Laboratories, Corp. Due to Due to complaints received associated with cracked/split test...

Date: November 9, 2020
Company: Helena Laboratories, Corp.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Helena Laboratories, Corp. directly.

Affected Products

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.

Quantity: Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Helena Laboratories, Corp.

Helena Laboratories, Corp. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report