Ventana Medical Systems Inc: OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic

Is my product affected?

OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 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 OptiView DAB IHC Detection Kit (Part Number 760-700) due to increased reports of leaking and sticking reagent dispensers in the horseradish peroxidase (HRP) component. The same issue affects other related products including iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II. A total of 12,028 units have been distributed worldwide across numerous countries including the United States, Canada, Australia, India, Japan, Germany, and Brazil.

The affected products are identified by specific lot numbers: Y19271, Y11625, Y24225, and Y15571, with UDI 04015630984039. The recall source does not specify a remedy or instructions for what affected consumers should do.

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: 12028 units Lot/code info: UDI 04015630984039, Lot Numbers: Y19271, Y11625, Y24225, Y15571

Source

Official record: FDA (Device enforcement) ↗

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

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