# FDA recall Z-2339-2017

> **bioMerieux, Inc.** · Class II · device recall initiated 2017-05-15.

## Product

VIDAS Testosterone, Ref 30418

## Reason for recall

Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.

## Distribution

AR, CA, CO, GA, IL, IA, MI, MN, MT, NY, OK, TN, TX, WY, Columbia, Costa Rica, El Salvador, France, Hong Kong, Jordan, Nicaragua, Russian Fed., Sri Lanka, Sweden, Ukraine

## Key facts

- **Recall number:** Z-2339-2017
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-15
- **Report date:** 2017-07-19
- **Termination date:** 2020-06-11

- **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-2339-2017

## Citation

> AI Analytics. FDA recall Z-2339-2017. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2339-2017. Source: US FDA. Licensed CC0.

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