Health Canada — Medical Devices · Canada · 2016-02-08 · 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 above. No AI-generated text appears on this page. How we use AI →
Archived by the issuing authority — kept for reference
Reported risk: In Sept 2015, Sekisui began receiving complaints of crystal formation on R2 when left on-board an automated analyzer for an extended period. Sekisui has confirmed through testing that the chromophore used in the R2 will come out of solution and form a crystal when left on-board and exposed to air.
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.