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Class IIOngoing

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

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Siemens Healthcare Diagnostics, Inc.
Reason
The potential for falsely elevated results.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99726…

Products

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

    Codes/lots: Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;Quantity: 42940 units (3938 US, 39002 OUS)Recall no. Z-3335-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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