Z-3335-2026Class II

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

Name: Z-3335-2026 Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2026-08-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics, Inc. / initiated 2026-08-17 / Open, Classified

FDA source

Recall record

Recall number: Z-3335-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-17
Posted: 2026-10-01
Recalling firm: Siemens Healthcare Diagnostics, Inc.
Product: Atellica CH Revised C-Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223;
Product code: DCN System, Test, C-Reactive Protein
Reason for recall: The potential for falsely elevated results.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 42940 units (3938 US, 39002 OUS)
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 codes and lots: Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3335-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3335-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-10-07	2026-09-30

Product code DCN

K221119Class IIRCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc. / cleared 2023-03-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)