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

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  Reason
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  Affected products

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