# FDA recall Z-0561-2019

> **Helena Laboratories, Inc.** · Class II · device recall initiated 2017-02-24.

## Product

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

## Reason for recall

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.

## Distribution

US:  Products under control of Manufacturer in TX    OUS: Four International Distributors - Australia, Netherlands, Italy, and England

## Key facts

- **Recall number:** Z-0561-2019
- **Recalling firm:** Helena Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-02-24
- **Report date:** 2018-12-12
- **Termination date:** 2023-10-20

- **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-0561-2019

## Citation

> AI Analytics. FDA recall Z-0561-2019. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0561-2019. Source: US FDA. Licensed CC0.

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