ADVIA CHEMISTRY SYSTEMS (2016-10-07)

Starting date:

October 7, 2016

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-60718

• Reason
• Affected products

Affected Products

A, ADVIA CHEMISTRY SYSTEMS - CHEMISTRY CALIBRATORS
B. ADVIA CHEMISTRY SYSTEMS - CHEMISTRY CALIBRATORS

Reason

Siemens has confirmed that the DBIL_2 assigned calibrator values (ACV) currently assigned to certain lots may cause, on average, a positive proportional bias of approximately 41% on patient samples compared to the reference method for direct bilirubin measurement. Due to the proportional bias, the differences become greater as the concentration of DBIL_2 increases. Quality control (QC) material is also affected by this issue. Depending on the quality control concentrations and ranges used by the laboratory, quality control may not detect this issue.

Affected products