Product Wiki · Recalls · Health Canada — Medical Devices

ADVIA Centaur System — recall 57596

Health Canada — Medical Devices · Canada · 2018-01-12 · Type III

As described by Health Canada — Medical Devices: ADVIA Centaur System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay and ADVIA Centaur CP System - B-Type Natriupretic Peptide (BNP), TSH3-ULTRA (TSH3-UL) Assay (2017-12-21)

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Agency
Health Canada — Medical Devices
Recall identifier
57596
Date of alert
2018-01-12
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The ADVIA Centaur CP, XP and XPT systems will not expire the multi-diluent 15 pack at the end of the required 7-day on board stability (obs), if any of the affected B-type natriuretic peptide (BNP) or TSH3-UL lots are present on the system(s) when performing onboard dilutions. On the ADVIA Centaur XPT only, the system becomes inoperable under certain specific conditions.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-system-b-type-na

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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