# FDA recall Z-2761-2019

> **Helena Laboratories, Corp.** · Class II · device recall initiated 2017-12-07.

## Product

Cascade Abrazo aPTT Test Card, Model 5722, For Export Only.  The firm name on the label is Helena Laboratories, Beaumont, TX.

## Reason for recall

Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.

## Distribution

Distribution was made to Germany and Australia.  There was no U.S. distribution.

## Key facts

- **Recall number:** Z-2761-2019
- **Recalling firm:** Helena Laboratories, Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-07
- **Report date:** 2019-10-09
- **Termination date:** 2020-06-09

- **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-2761-2019

## Citation

> AI Analytics. FDA recall Z-2761-2019. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-2761-2019. Source: US FDA. Licensed CC0.

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