Advia Chemistry Systems (2013-09-06)

Starting date:

September 6, 2013

Posting date:

September 27, 2013

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-35929

• Reason
• Affected products

Recalled products

1. Advia Chemistry System - Advia 1650 Analyzer - Class 2
2. Advia 1200 Chemistry System -Instrument Class 2
3. Advia Chemistry System - Advia 1800 Analyzer Class 2
4. Advia Chemistry System - Advia 2400 Analyzer Class 2

Reason

Siemens has confirmed that the affected devices will report results calculated using the ratio parameters feature without error flags when underlying individual test results used as part of the calculation are flagged. In cases where an error flag suppresses a numerical result, a ratio calculation will not be performed. If a numerical result is generated with a flag, the ratio will be reported without a flag.

Affected products