# FDA recall Z-1222-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2019-03-11.

## Product

VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658    Product Usage:  The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides, VITROS Chemistry Products MicroTip Reagents, and VITROS Immunodiagnostic Products Reagents

## Reason for recall

One of the software algorithms used to detect sample dispense errors was inadvertently disabled.  Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.

## Distribution

Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, IL, OH, TX, and VA.    The products were distributed to the following foreign countries:  Australia, Belgium, Canada, Chile, Columbia, France, India, Italy, Japan, Portugal, Singapore, Spain, United Kingdom

## Key facts

- **Recall number:** Z-1222-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-11
- **Report date:** 2019-05-01
- **Termination date:** 2020-12-07

- **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-1222-2019

## Citation

> AI Analytics. FDA recall Z-1222-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1222-2019. Source: US FDA. Licensed CC0.

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