# FDA recall Z-0074-2018

> **Biomerieux Inc** · Class II · device recall initiated 2017-10-11.

## Product

VITEK2 GP-ID, REF 21342 IVD

## Reason for recall

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM)  in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card.  In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM)  strain is positive.  As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-0074-2018
- **Recalling firm:** Biomerieux Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-11
- **Report date:** 2017-11-15
- **Termination date:** 2020-11-09

- **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-0074-2018

## Citation

> AI Analytics. FDA recall Z-0074-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0074-2018. Source: US FDA. Licensed CC0.

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