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 reported...

Date: February 24, 2017
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

Quantity: 27 kits

Why Was This Recalled?

Due to some cards in this lot reported to have experienced variations in results, (verified by 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