# FDA recall Z-0273-2018

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2017-06-12.

## Product

VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc.    For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

## Reason for recall

The firm identified the potential for biased results to be generated when processing VITROS PHYT Slide product with citrate plasma specimen samples.  The current Instructions for Use (IFU) and Assay Summary Chart state serum, heparin plasma, and citrate plasma as acceptable specimen types for use with the PHYT assay.

## Distribution

Worldwide Distribution -  US Distribution including  Puerto Rico and the following countries: Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Poland, Singapore, Spain, Russia and Venezuela.

## Key facts

- **Recall number:** Z-0273-2018
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-12
- **Report date:** 2018-01-03
- **Termination date:** 2020-08-11

- **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-0273-2018

## Citation

> AI Analytics. FDA recall Z-0273-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0273-2018. Source: US FDA. Licensed CC0.

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