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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