# FDA recall Z-2019-2024

> **Ortho-Clinical Diagnostics, Inc.** · Class III · device recall initiated 2024-05-08.

## Product

VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of vitamin B12 - Product Code: 6800872

## Reason for recall

The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure. The issue is detectable by the user when the product fails to meet the required range during processing of RV Level 2 of this lot. There is a potential for a delay in patient test results should the user have a need to switch to an alternate method of range verification including use of an alternate lot.  As this issue affects the upper limit range verification, there is no impact to VITROS Immunodiagnostic Products Vitamin B12 assay performance. Were the assay to not perform as expected, the failure would be detectable by Quality Control. Past patient sample results are unaffected, and no review of reported results is required.

## Distribution

Worldwide - US Nationwide and the country of Columbia.

## Key facts

- **Recall number:** Z-2019-2024
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-08
- **Report date:** 2024-06-12

- **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-2019-2024

## Citation

> AI Analytics. FDA recall Z-2019-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2019-2024. Source: US FDA. Licensed CC0.

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