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Advia Centaur Systems — recall 48385

Health Canada — Medical Devices · Canada · 2012-12-10 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 48385
Date of alert: 2012-12-10
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 has received complaints regarding a perceived increased rate of reactive results with specific Advair Centaur HBCT Assay kit lots, that do not correspond with other HBV Serological Markers. HBCT Readypack lot numbers ending in 044, 045, and 046 do not meet the specificity claims in the IFU . Product code 07566733 is used with the Advia Centaur, Advia Centaur XP, and Advia Centaur CP systems.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-systems

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Advia Centaur Systems — recall 48385

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