# FDA recall Z-1536-2020

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2020-02-13.

## Product

Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin  SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.

## Reason for recall

Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

## Distribution

Nationwide  Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus,  Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Azerbaijan,  Bahamas, Bahrain, Bangladesh, Benin, Bosnia Herzegovina,  Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Congo, Ecuador, Egypt, French Guinea, Georgia, Guadeloupe, Hong Kong, India, Indonesia, Iraq, Iran, Israel, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lesotho, Libya, Macedonia, Malawi, Malaysia, Mali, Mexico, Montenegro, Morocco, Mozambique, Myanmar, New Zealand, Nigeria, Oman,  Pakistan, Peru, Philippines, Qatar, Republic if Yemen, Republic Korea, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, South Africa, Swaziland, Taiwan, Ta

## Key facts

- **Recall number:** Z-1536-2020
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-13
- **Report date:** 2020-04-01
- **Termination date:** 2021-04-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1536-2020

## Citation

> AI Analytics. FDA recall Z-1536-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1536-2020. Source: US FDA. Licensed CC0.

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