Official recall record

Atellica CH Diluent

Health Canada — Medical Devices · 2025-02-26 · CanadaType II

Issuing authority: Health Canada — Medical Devices
Published: 2025-02-26
Country of alert: Canada
Alert level: Type II
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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