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Health Canada Medical devices

Atellica CH Diluent

Issued February 26, 2025
Issue
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 start date: February 14, 2025
Hazard description
Sterility
Product
Product name
Atellica CH Diluent
Reference
ID
RA-77027