Medical device manufacturer, Abbott Molecular Incorporation, has issued an field advisory notice concerning the Vysis FISH Pretreatment Reagent Kit, [List number 02J03-032]; Vysis Paraffin Pretreatment Reagent Kit, [List number 02J02-032]; Paraffin Pretreatment Reagent Kit II, [List number 07J02-002]; Protease I, 250mg x 2 Vials, [List number 02J08-032] respectively.
The manufacturer identified protease vials that were under filled and over filled. This may result in under or over digestion of the specimens and controls.
According to the manufacturer, under or over digestion of specimens or controls could cause FISH assays to be difficult to interpret or produce invalid/uninformative results. An invalid/uninformative control slide or specimen slide would result in the need to perform a repeat analysis with fresh control slides and specimen slide(s). There is no impact on results generated for slides that produce valid and interpretable results.
According to the local supplier, the affected devices were distributed in Hong Kong. For details, please refer to the attached field advisory notice. If you are in possession of the product, please contact your supplier for necessary actions.