# FDA recall Z-0807-2018

> **Ortho Clinical Diagnostics Inc** · Class III · device recall initiated 2017-07-10.

## Product

VITROS Chemistry Products Performance Verifier is used as an assayed control to monitor the performance on VITROS 250/350/5, 1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.      Used as a control for the VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

## Reason for recall

VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements for the AST Analyte (only) when the product is stored refrigerated for up to 6 months.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0807-2018
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-10
- **Report date:** 2018-03-07
- **Termination date:** 2020-08-06

- **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-0807-2018

## Citation

> AI Analytics. FDA recall Z-0807-2018. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-0807-2018. Source: US FDA. Licensed CC0.

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