Z-1551-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2025
- Initiation Date
- March 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Reason for Recall
Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
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.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
Code Information
Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.