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ADVIA CENTAUR SYSTEM — recall 53715

Health Canada — Medical Devices · Canada · 2015-09-08 · Type III

As described by Health Canada — Medical Devices: ADVIA CENTAUR SYSTEM - HBSAGII (HBSII) ASSAY (DONOR SCREEN TRANSPLANT) (2015-08-25)

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Agency
Health Canada — Medical Devices
Recall identifier
53715
Date of alert
2015-09-08
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: Manufacturer has identified an error on the Advia Centaur confirmatory card that is included in Advia centaur HBSAGII reagent lot 109056 (kit lots 55825056, 56167056 and 56244056). The error causes an interpretation of 'invalid' and a flag of 'CONF n/a' when the HBSAGII positive control is tested with the HBSAGII confirmatory (CONF) assay.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-system-hbsagii-h

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