Device product
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Z-2027-2025
Product summary
- Event
- Event 96952
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,625 units (1450 US, 175 OUS)
- Official record key
device-enforcement:Z-2027-2025
Official wording
Reason: 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.
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.
Derived failure modes
-
Unknown
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.