# FDA recall Z-0476-2019

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2018-10-08.

## Product

VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC)  Product Code: 6801728  UDI (10758750006793)

## Reason for recall

VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

## Distribution

Nationwide  Foreign:   Australia  Belgium  Bermuda, HM11  Brazil  Canada L3R 4G5   Chile  China  Colombia  Denmark  France  Germany  India  Italy  Japan  Mexico  Norway  Poland  Portugal  Russia  Singapore   Spain  Sweden  The Netherlands  United Kingdom

## Key facts

- **Recall number:** Z-0476-2019
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-08
- **Report date:** 2018-11-28
- **Termination date:** 2022-10-13

- **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-0476-2019

## Citation

> AI Analytics. FDA recall Z-0476-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0476-2019. Source: US FDA. Licensed CC0.

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