Atellica CH 930 Analyzer (2019-03-24)

Starting date:

March 24, 2019

Posting date:

April 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69782

Last updated: 2019-04-30

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  Reason
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  Affected products

Affected Products

Atellica CH 930 Analyzer

Reason

Siemens healthcare diagnostics is informing customers regarding an issue on the Atellica CH 930 analyzers, which are installed with Atellica Solution Software (SW) versions v1.17 SP2 (SMN 11469659) and lower where a difference in results of greater than 10% has been observed between auto-diluted and manually diluted patient samples for results above the assay measuring interval on the Atellica CH 930 Analyzer. Samples within the measuring interval do not require dilution and are not impacted.

Affected products