# FDA recall Z-0471-2021

> **Ortho Clinical Diagnostics Inc** · Class III · device recall initiated 2020-10-16.

## Product

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

## Reason for recall

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

## Distribution

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

## Key facts

- **Recall number:** Z-0471-2021
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-10-16
- **Report date:** 2020-11-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0471-2021

## Citation

> AI Analytics. FDA recall Z-0471-2021. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0471-2021. Source: US FDA. Licensed CC0.

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