Class II — Potential Health Hazard

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

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC Recalled by Helena Laboratories, Inc. Due to Due to some cards in this lot experiencing...

Date: April 20, 2016
Company: Helena Laboratories, Inc.
Status: Terminated
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, Inc. directly.

Affected Products

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

Quantity: 12 Kits

Why Was This Recalled?

Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

Where Was This Sold?

This product was distributed to 1 state: TX

Affected (1 state)Not affected

About Helena Laboratories, Inc.

Helena Laboratories, Inc. has 5 total recalls tracked by RecallDetector.

Related Recalls

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