Product Wiki · Recalls · Health Canada — Medical Devices

CMV IGM for ELECSYS and COBAS E and Diluent Universal (2015-02-18) — recall 53371

Health Canada — Medical Devices · Canada · 2015-03-05 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
53371
Date of alert
2015-03-05
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: This recall is related to a potential reduction in the signal of the Elecsys CMV IGM assay when used in combination with some specific Lots of Diluent Universal which may lead to false negative results for patients samples with high reactivity against one specific antigen. This may be affected by reduced cut-off values which may lead to a false negative result when the affected combination is used. The signal reduction has only minor effects on the calibrators and controls.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cmv-igm-elecsys-and-cobas-e-an

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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.