Z-1549-2024 Class II Ongoing
FDA device recall Z-1549-2024 was initiated by Siemens Healthcare Diagnostics, Inc. on Mar 13, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 8721 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 24, 2024
- Initiation Date
- Mar 13, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8721 units
Product Description
Reason for Recall
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.¿
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1549-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026