Device recall
Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
- Recall number
- Z-3335-2026
- Event id
- 99726
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Report date
- Oct 7, 2026
- Posted
- Oct 1, 2026
- Initiated
- Aug 17, 2026
- Center classification date
- Sep 30, 2026
- Product code
- DCN
- Device type
- System, Test, C-Reactive Protein
- Reason
- The potential for falsely elevated results.
- Root cause
- Under Investigation by firm
- Quantity
- 42940 units (3938 US, 39002 OUS)
- Code info
- Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K221119
- Location
- Tarrytown, NY, United States