# FDA recall Z-0772-2024

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2023-11-27.

## Product

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925    VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

## Reason for recall

Affected lots may experience increased calibration failures or an increase in falsely elevated results.

## Distribution

Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.

## Key facts

- **Recall number:** Z-0772-2024
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-27
- **Report date:** 2024-01-31

- **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-0772-2024

## Citation

> AI Analytics. FDA recall Z-0772-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0772-2024. Source: US FDA. Licensed CC0.

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