Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L

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.

Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

On May 22, 2025 URGENT FIELD SAFETY NOTICE letters were sent to OUS customers and URGENT MEDICAL DEVICE CORRECTION letters were sent to US customers. Customer Actions Please discontinue use of and discard all inventory of the diluent lot number listed in the table above (Products Section). If lot number 0000195412 is currently on your analyzer, remove the bottle and replace with an alternate lot number. See Appendix for detailed instructions. Review your inventory of this product to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

• FDA enforcement recordOfficial FDA database entry for Z-2027-2025
• FDA 510(k) clearance · K151767The device's official FDA premarket clearance record
• FDA device classification · JJEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.2160The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Siemens Healthcare Diagnostics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.