Ventana Medical Systems Inc: NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic

Is my product affected?

NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic

• UPC 04015630970254

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

What happened

Ventana Medical Systems Inc. is recalling 3,122 units of NEXES VEN IVIEW DAB DET KT JPN-US EXPORT (Ventana Part Number 760-041, Roche GMMI 05266084001) in vitro diagnostic kits worldwide. The recall was initiated due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers found in the iView, ultraView, and OptiView detection kits, as well as in the CINtec PLUS Cytology Kit and Hematoxylin II products. The affected lot number is Y15392 (UDI 04015630970254), and the recalled units were distributed to numerous countries including the United States, Canada, Mexico, Brazil, Argentina, and many others across Europe, Asia, and the Pacific region.

The source document 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: 3122 units Lot/code info: UDI 04015630970254, Lot Number: Y15392

Source

Official record: FDA (Device enforcement) ↗

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

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