Ventana Medical Systems Inc: ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

Is my product affected?

ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic

• UPC 04015630972296

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

What happened

Ventana Medical Systems Inc. is recalling the ultraView SISH Detection Kit (Ventana Part Number 780-001, Roche GMMI 05271967001) due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers, which are also found in iView, ultraView, and OptiView detection kits, as well as CINtec PLUS Cytology Kit and Hematoxylin II products. The recall affects 6 units with UDI 04015630972296 and Lot Number Y15133 that were distributed worldwide, including in the United States, 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, and China.

The source document 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: 6 units Lot/code info: UDI 04015630972296, Lot Number: Y15133

Source

Official record: FDA (Device enforcement) ↗

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

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