# FDA recall Z-0878-2023

> **Ortho-Clinical Diagnostics, Inc.** · Class II · device recall initiated 2022-11-17.

## Product

VITROS Immunodiagnostic Products Intact PTH Reagent Pack-  IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin)  Catalog Number: 6802892

## Reason for recall

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Bermuda HM12, Brazil, Canada L3R 4G5, Chile, China, Colombia,  Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia,  Singapore, Spain, Sweden, The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-0878-2023
- **Recalling firm:** Ortho-Clinical Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-17
- **Report date:** 2023-01-11

- **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-0878-2023

## Citation

> AI Analytics. FDA recall Z-0878-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0878-2023. Source: US FDA. Licensed CC0.

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