Ventana Medical Systems Inc: iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic

Is my product affected?

iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic

• UPC 04015630971749

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

What happened

Ventana Medical Systems Inc is recalling 1,980 units of iView DAB IHC Detection Kit and related reagent dispensers distributed worldwide due to increased reports of leaking and sticking horseradish peroxidase (HRP) dispensers. The affected products include the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II. The recalled lot numbers are Y11834 and Y24245, identified by UDI 04015630971749.

The products were distributed internationally across numerous countries including the United States, Argentina, Australia, Brazil, Canada, China, Germany, India, Japan, Mexico, and many others. The source document does not specify a remedy or next steps that consumers should take.

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: 1980 units Lot/code info: UDI 04015630971749, Lot Numbers: Y11834, Y24245

Source

Official record: FDA (Device enforcement) ↗

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

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