Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1549-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 13, 2024

Date Posted: April 24, 2024

Recall Number: Z-1549-2024

Event ID: 94260

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.

Status: Ongoing

Product Quantity: 8721 units

Code Information:

UDI-DI: 00630414610849 All lots

Distribution Pattern:

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.¿

Voluntary or Mandated:

Voluntary: Firm initiated