# FDA recall Z-1108-2021

> **Helena Laboratories, Corp.** · Class II · device recall initiated 2021-01-05.

## Product

Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

## Reason for recall

Intermittent potential for shorter than expected clot times.

## Distribution

Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.

## Key facts

- **Recall number:** Z-1108-2021
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-05
- **Report date:** 2021-02-17
- **Termination date:** 2024-11-19

- **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-1108-2021

## Citation

> AI Analytics. FDA recall Z-1108-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1108-2021. Source: US FDA. Licensed CC0.

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