Recall archive / FDA device enforcement
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and so... — FDA record Z-1549-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 13, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 8721 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1549-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00630414610849 All lots |
Match all identifying details in the current notice. A brand name alone is not enough.
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.¿
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 24, 2024
- Recall initiation date
- Mar 13, 2024
- Center classification date
- Apr 16, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.