# FDA recall Z-0247-2022

> **Ortho-Clinical Diagnostics, Inc.** · Class III · device recall initiated 2021-10-15.

## Product

VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427  For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems

## Reason for recall

Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-HBc IgM Controls Lot 1690 Controls Values booklet contained information for the incorrect product. While the accuracy of patient test results is not affected by this issue, there is a potential for delayed results due to the troubleshooting of Quality Control results.

## Distribution

US (Domestic) distribution to states of: AZ, CA, CO, CT, FL, GA, LA, MA, MO, NJ, NY, OK, SC, SD, TX, UT, WA, WI, and WV. OUS (Foreign) distribution to Colombia.

## Key facts

- **Recall number:** Z-0247-2022
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-15
- **Report date:** 2021-11-24
- **Termination date:** 2023-12-18

- **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-0247-2022

## Citation

> AI Analytics. FDA recall Z-0247-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0247-2022. Source: US FDA. Licensed CC0.

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