# FDA recall Z-2165-2018

> **BioMerieux SA** · Class II · device recall initiated 2018-03-23.

## Product

The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable.     A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

## Reason for recall

A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.

## Distribution

International distribution.

## Key facts

- **Recall number:** Z-2165-2018
- **Recalling firm:** BioMerieux SA
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-23
- **Report date:** 2018-06-20
- **Termination date:** 2020-06-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marcy L'Etoile, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2165-2018

## Citation

> AI Analytics. FDA recall Z-2165-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2165-2018. Source: US FDA. Licensed CC0.

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