FDA-Device2025-07-02Class II
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
Affected count
1,625 units (1450 US, 175 OUS)
Manufactured in
511 Benedict Ave, Tarrytown, NY, United States
Products
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2027-2025Don't want to check this manually?
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