# FDA recall Z-2770-2017

> **Biomerieux Inc** · Class II · device recall initiated 2017-05-16.

## Product

VITEK 2 Gram Negative test kits containing colistin (cs01n)

## Reason for recall

The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with  the VITEK¿ 2  AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).

## Distribution

Domestic: NC.      Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.

## Key facts

- **Recall number:** Z-2770-2017
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-16
- **Report date:** 2017-08-02
- **Termination date:** 2019-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2770-2017

## Citation

> AI Analytics. FDA recall Z-2770-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2770-2017. Source: US FDA. Licensed CC0.

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