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Atellica ch diluent

Official notice

26 Feb 2025

MediumHealth Canada

An official Health Canada notice concerns Atellica ch diluent. 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 Published 2025-02-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77027

Official notice

2025-02-26

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77027

Lots

0000191602, bottle

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Affected products

Product 1

Affected products - Atellica CH Diluent, Lot or serial number - 191602, Model or catalogue number - 11099300

Product 2

Affected products - Atellica CH Diluent, Lot or serial number - 0000195412, Model or catalogue number - 11099300

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Atellica Ch Diluent.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

77027

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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