Ventana Medical Systems Inc: OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic

Is my product affected?

OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic

• UPC 04015630983834

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

What happened

Ventana Medical Systems Inc. is recalling the OptiView Amplification Kit (Part Number 760-099) due to increased reports of leaking and sticking reagent dispensers in horseradish peroxidase (HRP) components. The same leaking and sticking issue has also been reported in iView and ultraView detection kits, as well as CINtec PLUS Cytology Kit and Hematoxylin II products. A total of 5,040 units have been affected, specifically those with UDI 04015630983834 and lot numbers Y15435, Y19322, or Y22447.

The affected products were distributed worldwide, including throughout the United States and to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, Germany, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Peru, Philippines, Singapore, Taiwan, Thailand, Uruguay, and Vietnam. 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: 5040 units Lot/code info: UDI 04015630983834, Lot Numbers: Y15435, Y19322, Y22447

Source

Official record: FDA (Device enforcement) ↗

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

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