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Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Recalled July 2, 2025 · FDA recall Z-2027-2025 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
1,625 units (1450 US, 175 OUS)
Sold at
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
Description
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.
Product
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →