Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C-Reactive Protein

Recalling company

Siemens Healthcare Diagnostics, Inc.

Product

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

Reason

The potential for falsely elevated results.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 17, 2026

Reported

Oct 7, 2026

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.

Status

Ongoing

Quantity

42940 units (3938 US, 39002 OUS)

Lot / codes

Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;

Company location

Tarrytown, NY

Recall type

Voluntary: Firm initiated

Recall number

Z-3335-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3335-2026 in the FDA Enforcement Report. Also see FDA recall press releases.