# FDA recall Z-0433-2022

> **bioMerieux, Inc.** · Class II · device recall initiated 2021-09-22.

## Product

VIDAS LH, REF 30406-01

## Reason for recall

bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0433-2022
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-22
- **Report date:** 2022-01-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0433-2022

## Citation

> AI Analytics. FDA recall Z-0433-2022. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0433-2022. Source: US FDA. Licensed CC0.

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