Ventana Medical Systems Inc: ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic

Is my product affected?

ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic

• UPC 04015630984039

Check against the official notice below — it lists the full affected range.

What happened

Ventana Medical Systems Inc. is recalling the ultraView Universal DAB Detection Kit (part number 760-500) and related products due to increased reports of leaking and sticking reagent dispensers, specifically affecting horseradish peroxidase (HRP) dispensers used in detection kits and the CINtec PLUS Cytology Kit, as well as Hematoxylin II dispensers. Approximately 72,730 units have been distributed worldwide, including across the United States and multiple countries in Central America, South America, Asia, Europe, and Australia.

The affected products are identified by specific lot numbers (Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, and Y22147). The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China, Quantity: 72730 units Lot/code info: UDI 04015630984039, Lot Numbers: Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, Y22147

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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