# FDA recall Z-2875-2020

> **Ortho-Clinical Diagnostics** · Class II · device recall initiated 2020-07-13.

## Product

VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296

## Reason for recall

Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil,   Canada L3R 4G5, China, Denmark, France, Germany, Italy,   Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.

## Key facts

- **Recall number:** Z-2875-2020
- **Recalling firm:** Ortho-Clinical Diagnostics
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-13
- **Report date:** 2020-09-02
- **Termination date:** 2021-07-27

- **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-2875-2020

## Citation

> AI Analytics. FDA recall Z-2875-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2875-2020. Source: US FDA. Licensed CC0.

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