Ventana Medical Systems Inc: CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic

Is my product affected?

CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic

• UPC 04015630976287

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 (Ventana Part Number 805-100, Roche GMMI 06889549001) due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers and Hematoxylin II. The affected kits were distributed worldwide, including in the US, Canada, Japan, and numerous other countries. A total of 18 units are involved, specifically those with UDI 04015630976287 and Lot Numbers Y22162 or Y15546.

The recall notice 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: 18 units Lot/code info: UDI 04015630976287, Lot Numbers: Y22162, Y15546

Source

Official record: FDA (Device enforcement) ↗

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

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