# FDA recall Z-2142-2024

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2024-03-01.

## Product

VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).

## Reason for recall

Potential for positively biased results due to signal reduction over shelf life.

## Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.

## Key facts

- **Recall number:** Z-2142-2024
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-01
- **Report date:** 2024-06-19

- **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-2142-2024

## Citation

> AI Analytics. FDA recall Z-2142-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2142-2024. Source: US FDA. Licensed CC0.

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