Medical device recalls Moderate risk

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

Recall date
March 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1551-2025
FDA classification
Class II
Brand / firm
Siemens Healthcare Diagnostics, Inc.
Sold / distributed
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, La…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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