Recall Monitor
Health Products

Atellica CH Diluent

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Atellica CH Diluent
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: General public, Healthcare, Industry
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Atellica CH Diluent19160211099300

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

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