Ventana Medical Systems Inc: Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

Is my product affected?

Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

• UPC 04015630972135

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

What happened

Ventana Medical Systems Inc. is recalling Hematoxylin II reagent dispensers and horseradish peroxidase (HRP) dispensers used in iView, ultraView, OptiView detection kits, and CINtec PLUS Cytology Kit due to increased reports of leaking and sticking dispensers. The recall affects 71,640 units that were distributed worldwide, including throughout the United States and in countries such as Canada, Mexico, Brazil, Argentina, Australia, Japan, China, India, and many others. The affected products are identified by specific lot numbers: Y10759, Y17402, Y21312, Y13938, Y17403, and Y22561.

The source document does not specify a remedy or recommended action for consumers who may have affected products.

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: 71640 units Lot/code info: UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561

Source

Official record: FDA (Device enforcement) ↗

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

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