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Atellica CH Revised C Reactive Protein (RCRP) recallZ-1551-2025 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 11, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Software Design Change

What the company is doing

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.

Recall details

Recall number
Z-1551-2025
Status
Open, Classified
Initiated by the company
Mar 11, 2025
Posted by the FDA
Apr 10, 2025
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Product code
DCN
FDA submissions
K221119
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.¿ ¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿ ¿ ¿¿¿¿ ¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿¿¿ ¿¿¿¿¿¿¿¿ ¿¿¿¿¿ ¿ ¿¿¿¿¿¿

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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