Product Wiki · Recalls · Health Canada — Medical Devices

Advia Centaur Systems - Br (27.29) Asssays (2017-03-14) — recall 56758

Health Canada — Medical Devices · Canada · 2017-04-04 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56758
Date of alert
2017-04-04
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 the Advia Centaur BR (ca 27.29) assay does not dilute linearly when used with multi-diluent 1 kit lots ending in 2577 and all future lots until further notice. When diluted, some samples over-recover the expected neat value by greater than 120%.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-systems-br-2729-

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