Product Wiki · Recalls · Health Canada — Medical Devices

ADVIA CENTAUR SYSTEMS (2015-12-30) — recall 54829

Health Canada — Medical Devices · Canada · 2016-01-22 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
54829
Date of alert
2016-01-22
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: Not meeting the current High-Dose Hook Effect expectation in the Instructions For Use (IFU). The ADVIA Centaur systems PSA assay range is 0.01-100 ng/mL (μg/L). The ADVIA Centaur Systems PSA IFU states that patient samples with high total PSA levels can cause a paradoxical decrease in the Relative Light Units (RLUs) (high-dose hook effect). In this assay, patient samples with total PSA levels as high as 10,000 ng/mL (μg /L) will assay greater than 100 ng/mL (μg/L).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-systems-2015-12-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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