Class II

Medical Device Recall: Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

Siemens Healthcare Diagnostics, Inc. · May 22, 2025

Reason for Recall

Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.

States Affected

NATIONWIDE

Quantity Affected

1,625 units (1450 US, 175 OUS)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2027-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Siemens Healthcare Diagnostics, Inc. Medical Device Recall: Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300; | SafeCheck