Ventana Medical Systems Inc: ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

Is my product affected?

ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic

• UPC 04015630972135

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

What happened

Ventana Medical Systems Inc. is recalling the ultraView SISH DNP Detection Kit (Ventana Part Number 800-098, Roche GMMI 05907136001) due to increased reports of leaking and sticking reagent dispensers in the horseradish peroxidase (HRP) components. The affected product has UDI 04015630972135 and Lot Number Y17990, with 358 units distributed worldwide including to the US, Canada, and numerous countries across South America, Asia, Europe, and Australia.

The source document does not specify a remedy or recommended actions 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: 358 units Lot/code info: UDI 04015630972135, Lot Number: Y17990

Source

Official record: FDA (Device enforcement) ↗

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

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