AccuMAb Plus Bordetella pertussis /parapertussis DFA (2014-03-01) — recall 53151
Health Canada — Medical Devices · Canada · 2015-05-21 · Type III
🏛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 →
Archived by the issuing authority — kept for reference
Reported risk: Declining fluorescence for Bordetella pertussis. False negative results for Bordetella parapertussis. Bordetella parapertussis falsely identified as Bordetella pertussis. When reagent is used neat (undiluted) it may cause the bacteria smear to detach from the glass microscope slide, resulting in no visible fluorescence.
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.
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.