Health product recall

Atellica CH Diluent

Last updated

Summary

Product
Atellica CH Diluent
Issue
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products Lot or serial number Model or catalogue number
Atellica CH Diluent 191602 11099300
Atellica CH Diluent 0000195412 11099300

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave, Tarrytown, New York, United States, 10591
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-77027

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