FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
- Recall number
- Z-1551-2025
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
- Status
- Open, Classified
- Initiated
- 2025-03-11
- Posted
- 2025-04-10
- Terminated
- not on file
- Reason
- Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
- Root cause
- Software Design Change
- Action
- On March 11, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. " For both Atellica CH and Atellica CI analyzers, perform the instructions in Appendix B to temporarily reduce the measuring interval. o Until the measuring interval is restored, track additional reagent consumption as a result of these actions to report to Siemens Healthineers for future reimbursement/credit. " Additionally, for Atellica CH Analyzers, perform the instructions in Appendix C to remove rules for flagging of No Calculation results and to install Atellica Solution Software version 1.29.0 or higher. " Complete and return the Field Correction Effectiveness Check form attached to this letter within 30 days. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. Resolution A follow-up communication will be provided when Customer Actions are no longer required. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
- Quantity
- not on file
- 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.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿
- Lot, serial or model codes
- Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.
- 510(k) numbers
- K221119
- PMA numbers
- not on file
- Product code
- DCN
- Firm FEI
- 2432235
- Firm city
- Tarrytown
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28