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Health product recall

Advia Centaur Systems

Starting date:
August 2, 2012
Posting date:
August 20, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Labelling and Packaging
Audience:
General Public (GP), Healthcare Professionals, Hospitals
Identification number:
RA-15515

Recalled Products

A. Advia Centaur Systems-HIV1/0/2 Enhanced (EHIV) Assay (Donor Screen Transplan)

Reason

The Advia Centaur HIV 1/0/2 (EHIV) is not meeting the on board stability claims of 28 days as stated in the instructions for use when used on the Advia Centaur Systems.

Affected products

A. Advia Centaur Systems-HIV1/0/2 Enhanced (EHIV) Assay (Donor Screen Transplan)

Lot or serial number

More than 30 numbers, contact manufacturer

Model or catalog number

01463908

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.