Atellica CI Analyzer. Catalog Numbers: 10947347.
FDA device recall Z-0597-2025 · posted 2024-12-04 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- JJE
- Quantity 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
- Date initiated
- 2024-11-04
- Date posted
- 2024-12-04
- Location
- Tarrytown, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) (K222116) | Siemens Healthcare Diagnostics, Inc. | 2023-07-13 |