Z-1549-2024Class II

Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium...

Name: Z-1549-2024 Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2024-03-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-03-13 / Open, Classified / root cause: design

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2024-03-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1549-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-13
Posted: 2024-04-16
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
Product code: JIY Photometric Method, Iron (Non-Heme)
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.¿
Product codes and lots: UDI-DI: 00630414610849 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1549-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1549-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-16

Product code JIY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)