FDA Medical devices recall ·
Atellica CH Diluent - CONS 2 x 1.5L recall
- Recall number
- Z-2027-2025
- Date
- (initiated May 22, 2025)
- Company / brand
- Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave, Tarrytown, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,625 units (1450 US, 175 OUS)
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2027-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.