Recall Z-0597-2025 · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Atellica CI Analyzer. Catalog Numbers: 10947347.
| Date | Dec 4, 2024 (initiated Nov 4, 2024) |
| Status | Open, Classified |
| Reason | 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 |
| Quantity | 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, Pak |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) Siemens Healthcare Diagnostics, Inc., Jul 13, 2023 |