# FDA recall Z-0451-2021

> **Ortho Clinical Diagnostics Inc** · Class II · device recall initiated 2020-09-30.

## Product

VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2.    Product Code (Unique Identifier):   6199921 (10758750033355)

## Reason for recall

Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Chile, China, Colombia, India,   Japan, Singapore 609917, United Kingdom, Italy.

## Key facts

- **Recall number:** Z-0451-2021
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-30
- **Report date:** 2020-11-25
- **Termination date:** 2023-12-07

- **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-0451-2021

## Citation

> AI Analytics. FDA recall Z-0451-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0451-2021. Source: US FDA. Licensed CC0.

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