# FDA recall Z-2344-2018

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2018-05-09.

## Product

VITROS Chemistry Products PHYT Slides, Catalog Number 8298671.  in vitro diagnostic

## Reason for recall

There is a potential for imprecise results when using the slides.  Increase in imprecision when using PHYT coating 0165. This leads to higher and lower than expected results for both quality control samples and patient samples.

## Distribution

Worldwide distribution.  US nationwide, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden

## Key facts

- **Recall number:** Z-2344-2018
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-09
- **Report date:** 2018-07-11
- **Termination date:** 2020-08-18

- **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-2344-2018

## Citation

> AI Analytics. FDA recall Z-2344-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2344-2018. Source: US FDA. Licensed CC0.

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