# FDA recall Z-0120-2022

> **Ortho Clinical Diagnostics Inc** · Class II · device recall initiated 2021-09-10.

## Product

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)-  For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative Calibrator for the determination of IgG antibodies to SARS-CoV-2.  Product Code: 6199966

## Reason for recall

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results

## Distribution

Worldwide Distribution: US (Nationwide) in states of: AL, AR, AZ, CA, CO, DC, FL, ID, KS, KY, LA, ME, MI, MS, MO, NY, TN, TX and WV; and OUS (Foreign) in countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico,	Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Russia, Denmark,	Norway, Sweden, Belgium, and The Netherlands.

## Key facts

- **Recall number:** Z-0120-2022
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-10
- **Report date:** 2021-10-27
- **Termination date:** 2024-02-13

- **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-0120-2022

## Citation

> AI Analytics. FDA recall Z-0120-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0120-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*