Product Wiki · Recalls · Health Canada — Medical Devices

ADVIA CENTAUR SYSTEM AND CP SYSTEM (2016-07-29) — recall 55720

Health Canada — Medical Devices · Canada · 2016-08-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55720
Date of alert
2016-08-10
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 is issuing a field safety notice to customers to emphasize that the prostate-specific antigen (PSA) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. Siemens is providing a limit of quantitation (loq) for the ADVIA Centaur PSA assay at this time. The loq for PSA on the ADVIA Centaur CP will follow
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-system-and-cp-sy

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