Ventana Medical Systems Inc: ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic

Is my product affected?

ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic

• UPC 04015630970384

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 (US Part Number 760-098, Roche GMMI 05572037001) due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers, which are also found in related iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II products. The affected kit has UDI 04015630970384 and Lot Number Y15146, with 20 units distributed worldwide including locations across North America, South America, Europe, Asia, and the Pacific region.

The recall record does not specify a remedy or recommended 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: 20 units Lot/code info: UDI 04015630970384, Lot Number: Y15146

Source

Official record: FDA (Device enforcement) ↗

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

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