# FDA recall Z-2129-2023

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2023-05-08.

## Product

VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.  VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.  Product Code: 6801704

## Reason for recall

Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM.  Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany,  India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden ,  The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-2129-2023
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-08
- **Report date:** 2023-07-19

- **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-2129-2023

## Citation

> AI Analytics. FDA recall Z-2129-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-2129-2023. Source: US FDA. Licensed CC0.

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