Product Wiki · Recalls · Health Canada — Medical Devices

Advia Centaur, Centaur CP, and Centaur XP Systems — recall 51100

Health Canada — Medical Devices · Canada · 2014-04-15 · Type III

As described by Health Canada — Medical Devices: Advia Centaur, Centaur CP, and Centaur XP Systems - HIV Ag/Ab Combo (Chiv) Assay (Donor Screen Transplant) (2014-03-28)

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Agency
Health Canada — Medical Devices
Recall identifier
51100
Date of alert
2014-04-15
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-centaur-cp-and-c

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