# FDA recall Z-1541-2020

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

## Product

Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge   -In vitro Diagnostic for the determination of  total bilirubin.  SMN: 10445146    Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista¿ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.

## 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-1541-2020
- **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-1541-2020

## Citation

> AI Analytics. FDA recall Z-1541-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-1541-2020. Source: US FDA. Licensed CC0.

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