Z-2027-2025 Class II Ongoing
FDA device recall Z-2027-2025 was initiated by Siemens Healthcare Diagnostics, Inc. on May 22, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1,625 units (1450 US, 175 OUS).
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;