# FDA recall Z-0058-2019

> **Ortho Clinical Diagnostics Inc** · Class II · device recall initiated 2018-07-12.

## Product

VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266

## Reason for recall

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

## Distribution

Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.

## Key facts

- **Recall number:** Z-0058-2019
- **Recalling firm:** Ortho Clinical Diagnostics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-07-12
- **Report date:** 2018-10-10

- **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-0058-2019

## Citation

> AI Analytics. FDA recall Z-0058-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0058-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*