Product Wiki · Recalls · Health Canada — Medical Devices

CD8 PE (Leu 2a) Reagent (2014-12-22) — recall 52613

Health Canada — Medical Devices · Canada · 2015-01-14 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
52613
Date of alert
2015-01-14
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: May be hazardous to health: The CD8 PE reagent is contaminated with CD4 FITC. CD4 cells will be expressed along the FITC axis. Any marker that is stained for on the FITC axis will contain this incorrectly stained CD4 population. With subsequent down gating, the results will appear as if the CD4 population is not present. This could result in the unnecessary intensification of therapy for patients already known to have reductions in their CD4 levels.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cd8-pe-leu-2a-reagent-2014-12-

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.

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.