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

FDA device recall Z-2027-2025 · posted 2025-06-25 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JJE

Quantity affected

1,625 units (1450 US, 175 OUS)

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.

Date initiated

2025-05-22

Date posted

2025-06-25

Location

Tarrytown, NY

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