Z-2027-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 2, 2025
- Initiation Date
- May 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,625 units (1450 US, 175 OUS)
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
Code Information
Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;