Ventana OptiView DAB IHC Detection Kit Recalled for Leaking and Sticking
Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which the rubric defines as unlikely to cause adverse health consequences. The issue is a mechanical defect (leaking/sticking) without reported injuries.
Plain-English summary
Ventana Medical Systems Inc is recalling the OptiView DAB IHC Detection Kit (Ventana Part Number 760-700, Roche GMMI 06396500001). The recall involves 12,028 units distributed worldwide, including the United States, Canada, and various countries in Asia, Europe, and South America.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers. These dispensers are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II. The specific lot numbers affected are Y19271, Y11625, Y24225, and Y15571.
Users of these in vitro diagnostic devices should stop using the affected kits and contact Ventana Medical Systems for further instructions or replacement.
The recalled product
- Product
- OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 12,028
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 (5)
- UDI 04015630984039
- Lot Numbers: Y19271
- Y11625
- Y24225
- Y15571
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.
See all 12 products in this recall →Related recalls
Same manufacturer · Ventana Medical Systems Inc
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- HighMedical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results
FDA (Devices) · 2024-08-28
- HighVENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results
FDA (Devices) · 2023-01-18
- HighVentana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk
FDA (Devices) · 2022-07-20
- HighMedical Laboratory Instruments Recalled Due to Electrical Short Circuit Fire Risk
FDA (Devices) · 2022-04-13
Same hazard · leaking
See all →- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking
FDA (Devices) · 2025-05-07