Ventana Hematoxylin II and HRP Dispensers Recalled for Leaking and Sticking
Ventana Medical Systems is recalling Hematoxylin II and specific HRP dispensers due to increased reports of leaking and sticking.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls are assigned a severity score of 4 (Severe) or higher, as they are reasonably likely to cause serious adverse health consequences or death.
Plain-English summary
Ventana Medical Systems Inc is recalling Hematoxylin II (Ventana Part Number 790-22087, Roche GMMI 05277965001) and specific horseradish peroxidase (HRP) dispensers. The HRP dispensers are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit. The recall involves 71,640 units distributed worldwide, including the United States, Canada, and numerous countries in Asia, Europe, and South America.
The recall was initiated due to increased reports of leaking and sticking in the reagent dispensers for both the HRP components and the Hematoxylin II product. The affected lot numbers are Y10759, Y17402, Y21312, Y13938, Y17403, and Y22561, associated with UDI 04015630972135.
This is an FDA Class I recall. Users of these in vitro diagnostic products should stop using the affected units and contact Ventana Medical Systems for further instructions.
The recalled product
- Product
- Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 71,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI 04015630972135
- Lot Numbers: Y10759
- Y17402
- Y21312
- Y13938
- Y17403
- Y22561
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Ventana Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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