Ventana Medical Systems Inc: OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

Is my product affected?

OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic

• UPC 04015630984749

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

What happened

Ventana Medical Systems Inc. is recalling the OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. The same issue affects other detection kits including iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II. A total of 518 units with UDI 04015630984749 and Lot Number Y19318 have been distributed worldwide, including across the United States and 26 other countries.

The source document does not specify a remedy or course of action for affected consumers.

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: 518 units Lot/code info: UDI 04015630984749, Lot Numbers: Y19318

Source

Official record: FDA (Device enforcement) ↗

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

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