Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
FDA Recall #Z-2027-2025 — Class II — May 22, 2025
Product Description
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
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.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,625 units (1450 US, 175 OUS)
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
Code Information
Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated