Atellica CI Analyzer. Catalog Numbers: 10947347.
Reported: December 11, 2024 Initiated: November 4, 2024 #Z-0597-2025
Product Description
Atellica CI Analyzer. Catalog Numbers: 10947347.
Reason for Recall
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 559 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Bangladesh, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Malaysia, Netherlands, Oman, Pakistan, Paraguay, Peru, Philippines, Portugal, Qatar, Republic Korea, Romania, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom Great Britain, Vietnam.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica CI Analyzer. Catalog Numbers: 10947347.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 559 units.
Why was this product recalled? ▼
Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the IMT Diluent being empty while still displaying that volume is remaining. In this case Sodium (Na), Potassium (K) and Chloride (Cl) test results may be falsely elevated. Quality Control materials demonstrate the same behavior.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0597-2025.
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