Recall Z-0597-2025— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0597-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-04

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2024-11-04. It names one FDA 510(k) clearance: K222116. Product: Atellica CI Analyzer. Catalog Numbers: 10947347.. 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-04
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.·cleared 2023-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.