Health product recall – Atellica CH Diluent

Issue & Risk

Siemens Healthineers has confirmed, through the investigation of customer complaints, the presence of sodium hypochlorite (NaOCl) contamination in certain bottles of Atellica CH Diluent lot number 0000191602, bottle sequence numbers 00001-04400 (cartons 00001-02200) used on Atellica CH 930 and Atellica CI analyzers. Atellica IM assays are not affected. As a result of this issue, calibrator, quality control (QC), and patient results could be affected for any Atellica CH assay excluding sodium, potassium, and chloride. This issue is specific to Atellica CH Diluent lot number 0000191602. Unaffected alternate lots of this product are available.

Recall Details

Starting Date: February 26, 2025

Description:

What you should do/ Action taken

Contact the manufacturer if you require additional information.

Summary

Siemens Healthineers has identified sodium hypochlorite (NaOCl) contamination in certain bottles of Atellica CH Diluent, specifically lot number 0000191602, bottle sequence numbers 00001-04400 (cartons 00001-02200). This issue may impact calibrator, quality control (QC), and patient results for Atellica CH assays, excluding sodium, potassium, and chloride tests. Atellica IM assays are not affected. Siemens Healthineers has confirmed that unaffected alternative lots are available for use.

For more information on this recall, see the: Health product recall – Atellica CH Diluent