# FDA recall Z-1114-2022

> **Ortho-Clinical Diagnostics, Inc** · Class II · device recall initiated 2022-03-25.

## Product

VITROS Immunodiagnostic Products Prolactin Reagent Pack     Product Code: 1849793

## Reason for recall

Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

## Distribution

Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5  Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore  Spain Sweden United Kingdom

## Key facts

- **Recall number:** Z-1114-2022
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-25
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2022

## Citation

> AI Analytics. FDA recall Z-1114-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1114-2022. Source: US FDA. Licensed CC0.

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