# FDA recall Z-1675-2022

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2022-07-19.

## Product

VITROS XT 3400 Chemistry System with Version 3.7.2 and below  Product Code: 6844458

## Reason for recall

Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-1675-2022
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-19
- **Report date:** 2022-09-14

- **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-1675-2022

## Citation

> AI Analytics. FDA recall Z-1675-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1675-2022. Source: US FDA. Licensed CC0.

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