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 number

Z-1549-2024

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Status

Open, Classified

Initiated

2024-03-13

Posted

2024-04-16

Terminated

not on file

Reason

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.

Root cause

Device Design

Action

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

Quantity

8721 units

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Curacao, St¿Eus, Czech Republic, Denmark, Estonia, Finland, France, Germany, ¿ Greece, Hungary, India, Ireland, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, ¿¿¿¿ New Zealand, Norway, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United¿Kingdom.¿

Lot, serial or model codes

UDI-DI: 00630414610849 All lots

510(k) numbers

not on file

PMA numbers

not on file

Product code

JIY

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

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

Copy