Recall archive / FDA device enforcement
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. — FDA record Z-1551-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
- Reason
- Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- N/A
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1551-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portugal, Qatar, Romania, Saudi¿Arabia, Serbia, Singapore, Slovakia, Slovenia, South¿Africa, Spain, Sweden, Switzerland, Taiwan, U.A.E., Uganda, United¿Kingdom, Uzbekistan, Vatikancity.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 16, 2025
- Recall initiation date
- Mar 11, 2025
- Center classification date
- Apr 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.