# FDA recall Z-0594-2019

> **Helena Laboratories, Inc.** · Class II · device recall initiated 2016-04-20.

## 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    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.

## Reason for recall

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

## Distribution

US Distribution to state of TX and internationally to:  Australia, Netherlands, Italy, and England.

## Key facts

- **Recall number:** Z-0594-2019
- **Recalling firm:** Helena Laboratories, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-04-20
- **Report date:** 2018-12-19
- **Termination date:** 2024-02-15

- **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-0594-2019

## Citation

> AI Analytics. FDA recall Z-0594-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0594-2019. Source: US FDA. Licensed CC0.

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