Siemens Healthcare Diagnostics, Inc. Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica CI Analyzer and Atellica CH Analyzer Siemens Material Number (SMN): 11537211 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and sodium heparin) using the Atellica CI Analyzer and Atellica CH Analyzer Siemens Material Number (SMN): 11537211
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00630414610849 All lots
Products Sold
UDI-DI: 00630414610849 All lots
Siemens Healthcare Diagnostics, Inc. is recalling Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithi due to Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette w. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
Recommended Action
Per FDA guidance
Siemens issued Urgent Medical Device Correction (UMDC) ACHC24-03.A.US to US customers via FedEx beginning on 03/13/2024. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 03/13/2024. New customers who purchase the Atellica CH Iron3 assay on the Atellica CH and Atellica CI analyzers will receive the UMDC/UFSN, until the product issue is resolved. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Refer to short-term mitigation steps in Appendix B while Siemens works towards transitioning customers back to the Iron_2 assay. {The UMDC/UFSN provides instructions to Atellica Solutions customers with multiple analyzers to segregate Iron3 and the impacted assays (Chol_2, LDLC, and Trig_2) onto separate systems. Atellica Solutions customers with a single Atellica analyzer instructed to stop use of Iron3 and identify alternative methods for Iron testing]. 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 Siemens is actively working to ramp up the supply volume to support customer conversion to the Iron_2 assay. We anticipate being able to support an end to the mitigation within a six month timeframe. A follow up communication will be provided when Customer Actions are no longer required. These mitigations will remain in effect until the solution is provided
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026