Atellica CH Iron3 - IVD use in the quantitative measurement… recallZ-1549-2024 · Siemens Healthcare Diagnostics, Inc. · initiated Mar 13, 2024

Open, Classified

Is my device affected?

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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.
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Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number: Z-1549-2024
Status: Open, Classified
Initiated by the company: Mar 13, 2024
Posted by the FDA: Apr 16, 2024
Recalling firm: Siemens Healthcare Diagnostics, Inc.
Quantity: 8721 units
Product code: JIY
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.¿

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00630414610849 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 Iron3 (Iron3) 11537211
Siemens Healthcare Diagnostics Inc. · Photometric method, iron (non-heme)
1 recall0 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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