# FDA recall Z-3119-2017

> **bioMerieux, Inc.** · Class II · device recall initiated 2017-04-10.

## Product

eMAG System, Ref 418591    It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).

## Reason for recall

Some anomalies have been identified during manufacturing controls.

## Distribution

Worldwide Distribution: US (nationwide) to states of: GA, IL, IN, MA, NC & TX and to countries of: Austria, France, Germany, Hong Kong, Italy, Netherlands, Spain, Sweden, Switzerland, Thailand and United Kingdom.

## Key facts

- **Recall number:** Z-3119-2017
- **Recalling firm:** bioMerieux, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-04-10
- **Report date:** 2017-09-20
- **Termination date:** 2022-02-24

- **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-3119-2017

## Citation

> AI Analytics. FDA recall Z-3119-2017. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-3119-2017. Source: US FDA. Licensed CC0.

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