# FDA recall Z-0744-2020

> **Axis-Shield Diagnostics, Ltd.** · Class II · device recall initiated 2019-09-16.

## Product

Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

## Reason for recall

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

## Distribution

US Nationwide distribution in the states of CA, KY.

## Key facts

- **Recall number:** Z-0744-2020
- **Recalling firm:** Axis-Shield Diagnostics, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-09-16
- **Report date:** 2020-01-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dundee, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2020

## Citation

> AI Analytics. FDA recall Z-0744-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0744-2020. Source: US FDA. Licensed CC0.

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