# FDA recall Z-0801-2021

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2020-11-20.

## Product

VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.

## Reason for recall

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.

## Distribution

Worldwide distribution - US Nationwide distribution including the states of CA, CO, MA, MD, NC, OH, TX, VA, VT, and Belgium, Bermuda, Canada, China, France, Italy, Japan, Mexico, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom.

## Key facts

- **Recall number:** Z-0801-2021
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-20
- **Report date:** 2021-01-13
- **Termination date:** 2023-10-24

- **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-0801-2021

## Citation

> AI Analytics. FDA recall Z-0801-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0801-2021. Source: US FDA. Licensed CC0.

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