Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1551-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 11, 2025

Date Posted: April 16, 2025

Recall Number: Z-1551-2025

Event ID: 96440

Reason for Recall:

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

Status: Ongoing

Product Quantity: N/A

Code Information:

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

Distribution Pattern:

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.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿

Voluntary or Mandated:

Voluntary: Firm initiated