Advia Centaur, Centaur CP, and Centaur XP Systems - HIV Ag/Ab Combo (Chiv) Assay (Donor Screen Transplant) (2014-03-28)

Starting date:

March 28, 2014

Posting date:

April 15, 2014

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-39085

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  Reason
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  Affected products

Recalled products

1. Advia Centaur Sys-HIV Ag/Ab Combo (Chiv) Assay (Donor Screen Transplant)
2. Advia Centaur XP Sys-Hiv Ag/Ab Combo (Chiv) Assay (Donor Screen Transplant)
3. Advia Centaur CP Sys-HIV Ag/Ab Combo (Chiv) Assay (Donor Screen Transplant)

Reason

Siemens Healthcare Diagnostics has confirmed that certain samples may show human anti-mouse antibodies (HAMA) interference for the Advia Centaur HIV Ag/Ab combo (CHIV) assay. Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or animal serum products are prone to this interference and anomalous values may be observed. Additional information may be required for diagnosis.

Affected products