Recall Z-2027-2025 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
| Date | Jun 25, 2025 (initiated May 22, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 reporti |
| Quantity | 1,625 units (1450 US, 175 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151767 | Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Br Siemens Healthcare Diagnostics, Inc., Dec 11, 2015 |