Z-2027-2025Class II

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

Name: Z-2027-2025 Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2025-05-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-05-22 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300 on 2025-05-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2027-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-22
Posted: 2025-06-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 1,625 units (1450 US, 175 OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.
Product codes and lots: Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2027-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2027-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-07-02	2025-06-25

Product code JJE

K151767Class IITrinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP CalibratorSiemens Healthcare Diagnostics, Inc. / cleared 2015-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)