Reported Apr 24, 2024 · Ongoing
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI00630414610849 All lots
- Amount recalled
- 8721 units
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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