Ventana Medical Systems Inc: CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic

Is my product affected?

CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic

• UPC 04015630972807

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

What happened

Ventana Medical Systems Inc. is recalling the CINtec PLUS Cytology Kit (CE-IVD) due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers and Hematoxylin II. The affected product includes Ventana Part Number 605-100 and Roche GMMI 06889565001. A total of 748 units have been distributed worldwide, including across the US and numerous countries in North America, South America, Europe, Asia, and Oceania.

The recall involves specific lot numbers Y14122 and Y18107, which can be identified by UDI 04015630972807. 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: 748 units Lot/code info: UDI 04015630972807, Lot Numbers: Y14122, Y18107

Source

Official record: FDA (Device enforcement) ↗

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

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