Product Wiki · Recalls · Health Canada — Medical Devices

Advia Centaur Systems - HIV Ag/Ab Combo (CHIV) Assays (2013-09-17) — recall 50554

Health Canada — Medical Devices · Canada · 2013-10-17 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
50554
Date of alert
2013-10-17
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: The analytical sensitivity statements in the Advia Centaur / XP and Advia Centaur CP IFUs were based on one lot of reagent. Siemens evaluated the current P24 analytical sensitivity with multiple lots to determine if the HIV Ag / Ab combo (CHIV) assay is meeting the IFU statements. Five out of the seven lots evaluated on the Advia Centaur / XP and four out of seven lots evaluated on the Advia Centaur CP did not meet the statement in the IFU with regard to P24 analytical sensitivity. However, the CHIV assay is meeting the design requirements (Dir target < 1.5 IU/mL, Dir minimum < 2.0 IU/ml) and the CTS analytical sensitivity requirement of less than and equal to 2.0 IU/mL. =2.0 IU/ml.</p
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-systems-hiv-agab

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