ADVIA CHEMISTRY SYSTEM (2015-04-13)

Starting date:

April 13, 2015

Posting date:

May 6, 2015

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-53245

• Reason
• Affected products

Recalled Products

A. ADVIA CHEMISTRY SYSTEM - AMYLASE (AMYLAS) ASSAY
B. ADVIA 1200 CHEMISTRY SYSTEM - AMYLASE (AMYLAS) ASSAY

Reason

Amylase reagent kit for use on the ADVIA Chemistry Systems demonstrates an increased incidence of absorbance flags (U or U accompanied by U). Absorbance flags (U) indicate an abnormally high reagent blank absorbance exceeding the reagent blank limit. In some cases with these reagent lots, sample results may also have a sample absorbance (U) flag indicating a high absorbance for the sample that occurs in conjunction with the (U) flag. Amylase results can be generated with these flags.

Affected products