FDA (Devices) recall action 78942
The FDA (Devices) publishes a recall like this one as 12 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 12 pages.
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Ventana Medical Systems is recalling 20 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling Hematoxylin II and specific HRP dispensers due to increased reports of leaking and sticking.
Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling 6 units of the ultraView SISH Detection Kit due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT in vitro diagnostic kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling 748 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling iView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.