# FDA recall Z-0737-2018

> **Ventana Medical Systems Inc** · Class I · device recall initiated 2017-12-19.

## Product

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

## Reason for recall

Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.

## Distribution

Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

## Key facts

- **Recall number:** Z-0737-2018
- **Recalling firm:** Ventana Medical Systems Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-19
- **Report date:** 2018-03-07
- **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-0737-2018

## Citation

> AI Analytics. FDA recall Z-0737-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-0737-2018. Source: US FDA. Licensed CC0.

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