# FDA recall Z-3075-2017

> **Biomerieux Inc** · Class II · device recall initiated 2017-07-12.

## Product

VITEK¿ 2 Compact 15, REF numbers:  27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and yeast.

## Reason for recall

Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-3075-2017
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-12
- **Report date:** 2017-09-06
- **Termination date:** 2020-12-16

- **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-3075-2017

## Citation

> AI Analytics. FDA recall Z-3075-2017. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-3075-2017. Source: US FDA. Licensed CC0.

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