Product Wiki · Recalls · Health Canada — Medical Devices

VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System… — recall 58933

Health Canada — Medical Devices · Canada · 2019-03-08 · Type II

As described by Health Canada — Medical Devices: VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, VITROS XT 7600 Integrated System (2019-02-21)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
58933
Date of alert
2019-03-08
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A luminometer malfunction may occur after the system is shut down and restarted, due to the luminometer signal board parameters incorrectly reverting to the default settings. If this occurs, users will not be able to process any microwell assays until service is performed. In this scenario, an ortho-trained service representative must be dispatched to resolve the malfunction.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vitros-3600-immunodiagnostic-s

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.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.