Health product recall

ADVIA Centaur System - Folate Assay (2019-07-29)

Starting date:
July 29, 2019
Posting date:
August 16, 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-70719



Last updated: 2019-08-16

Affected Products

ADVIA Centaur System - Folate Assay

Reason

Siemens Healthcare Diagnostics has confirmed the potential for the ADVIA Centaur homocysteine assay (100 test kit smn 10310374; 500 test kit smn 10310375) to intermittently interfere with the folate assay when testing is performed on the ADVIA Centaur, ADVIA Centaur XP or ADVIA Centaur XPT systems. The interference is observed intermittently with only the first replicate of folate when the assay is tested immediately following homocysteine assay testing.

Affected products

ADVIA Centaur System - Folate Assay

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

6367974

6891541

Companies
Manufacturer

Siemens Healthcare Diagnostics Products Limited

Glyn Rhonwy

Llanberis, Gwynedd

LL55 4EL

UNITED KINGDOM