# FDA recall Z-3000-2018

> **Ventana Medical Systems Inc** · Class I · device recall initiated 2018-08-02.

## Product

OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099     Immunohistochemistry (IHC) for in vitro diagnostic use.

## Reason for recall

Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers.  A false negative IHC result may occur.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-3000-2018
- **Recalling firm:** Ventana Medical Systems Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-02
- **Report date:** 2018-09-26
- **Termination date:** 2021-11-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oro Valley, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3000-2018

## Citation

> AI Analytics. FDA recall Z-3000-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-3000-2018. Source: US FDA. Licensed CC0.

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