Health Canada — Medical Devices · Canada · 2016-04-29 · 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: Leica Biosystems recently became aware that Novocastra Liquid Mouse Monoclonal Antibody Calretinin only performed as expected with specific lots of diluents: - AR9352 (lots SLBL4196V, SLBL8154V, SLBM1997V, SLBM3199V) - AR9352-CN (lots SLBL8154V, SLBM1997V) - RE7133-CE (lot 6035000) - RE7133-CN (lot 6035115) In the event that the product is used with diluents other than those listed, it may not provide adequate staining. When used according to the instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. In these instances, the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of IHC / ISH staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm. This notice only applies to Novocastra Liquid Mouse Monoclonal Antibody Calretinin.
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.