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Product: Atellica CH Diluent - CONS 2 x 1.5L recallZ-2027-2025 · Siemens Healthcare Diagnostics, Inc. · initiated May 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2027-2025
Status
Open, Classified
Initiated by the company
May 22, 2025
Posted by the FDA
Jun 25, 2025
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1,625 units (1450 US, 175 OUS)
Product code
JJE
FDA submissions
K151767
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.

Product description

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

Code information (models, lots, serial numbers)

Siemens Material Number (SMN): 11099300; UDI-DI: 00630414595771; Lot Number: 0000195412;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

5 devices cleared under K151767 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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