# FDA recall Z-1551-2025

> **Siemens Healthcare Diagnostics, Inc.** · Class II · device recall initiated 2025-03-11.

## Product

Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

## Reason for recall

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

## Distribution

Domestic: Nationwide Distribution.  International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portugal, Qatar, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United¿Kingdom, Uzbekistan, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿   ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿  ¿¿¿¿¿¿

## Key facts

- **Recall number:** Z-1551-2025
- **Recalling firm:** Siemens Healthcare Diagnostics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-11
- **Report date:** 2025-04-16

- **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-1551-2025

## Citation

> AI Analytics. FDA recall Z-1551-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1551-2025. Source: US FDA. Licensed CC0.

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