Atellica CH Revised C-Reactive Protein (RCRP) recallZ-3335-2026 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 17, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
The potential for falsely elevated results.
FDA root cause category: Under Investigation by firm
What the company is doing
On August 17, 2026 Urgent Medical Device Correction letters were sent to customers. Customer actions: 1. Follow the instructions provided to set-up and calibrate the device. 2. Record the number of unused tests discarded in Step 3 on the Field Correction Effectiveness Check form for reimbursement or credit. 3. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 4. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 5. Retain this letter with your laboratory records and forward this letter to those who may have received the affected product.
Recall details
- Recall number
- Z-3335-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 17, 2026
- Posted by the FDA
- Oct 1, 2026
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 42940 units (3938 US, 39002 OUS)
- Product code
- DCN
- FDA submissions
- K221119
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jordan, Kenya, Korea, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, U.A.E., Uganda, United Kingdom , Uruguay, Uzbekistan, Vatikancity, Vietnam, Zaire.
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.
- Atellica CH Revised C-Reactive Protein (RCRP) 11537223Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, C-REACTIVE PROTEIN2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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