# FDA recall Z-0914-2018

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2017-09-22.

## Product

VITROS Chemistry Products DAT Performance Verifier IV  in vitro diagnostic

## Reason for recall

This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

## Distribution

Worldwide distribution: US Nationwide (including Puerto Rico), Bermuda, Australia, Brazil, Canada, Chile, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain, Poland, and Russia.

## Key facts

- **Recall number:** Z-0914-2018
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-22
- **Report date:** 2018-03-14
- **Termination date:** 2020-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rochester, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0914-2018

## Citation

> AI Analytics. FDA recall Z-0914-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0914-2018. Source: US FDA. Licensed CC0.

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