# FDA recall Z-0392-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2018-08-28.

## Product

VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489    For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System, to aid in the differential diagnosis of anemia

## Reason for recall

The reagent pack exhibits the potential for an increased frequency of calibration failures.

## Distribution

Worldwide Distribution: US (nationwide)  to the following US states:  AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VT, WA, WI, WV, and WY; and countries of:  Belgium, Bermuda, Brazil, Canada, Chile, Columbia, Denmark, France, Germany, India, Italy, Portugal, Spain, and UK.

## Key facts

- **Recall number:** Z-0392-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-28
- **Report date:** 2018-11-14
- **Termination date:** 2020-08-11

- **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-0392-2019

## Citation

> AI Analytics. FDA recall Z-0392-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0392-2019. Source: US FDA. Licensed CC0.

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