Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2027-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 22, 2025

Date Posted: July 2, 2025

Recall Number: Z-2027-2025

Event ID: 96952

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.

Status: Ongoing

Product Quantity: 1,625 units (1450 US, 175 OUS)

Code Information:

Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated