# FDA recall Z-2542-2025

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2025-08-11.

## Product

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

## Reason for recall

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

## Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedonia, Malaysia, Maldives, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan,  U.A.E., United¿Kingdom, Uruguay, Vatikancity, Vietnam, Zaire.

## Key facts

- **Recall number:** Z-2542-2025
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-11
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tarrytown, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2542-2025

## Citation

> AI Analytics. FDA recall Z-2542-2025. Retrieved 2026-09-21 from https://api.ai-analytics.org/recall/Z-2542-2025. Source: US FDA. Licensed CC0.

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