Ventana iView DAB IHC Detection Kit Recalled for Leaking and Sticking
Ventana Medical Systems is recalling iView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
Plain-English summary
Ventana Medical Systems Inc is recalling 1,980 units of the iView DAB IHC Detection Kit (Ventana part Number 760-091, Roche GMMI 05266157001). The recall involves specific lots identified by UDI 04015630971749 and Lot Numbers Y11834 and Y24245.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers. This issue affects the horseradish peroxidase (HRP) dispensers, which are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II.
The affected products were distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. Users of these in vitro diagnostic kits should check their inventory for the specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 1,980
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 (3)
- UDI 04015630971749
- Lot Numbers: Y11834
- Y24245
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 Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- 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
- 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
Similar recalls
- SevereVentana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects
FDA (Devices) · 2018-09-26
- SevereVentana ISH iView Blue Detection Kit Recalled for Leaking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana iVIEW Blue Plus Detection Kit Recalled for Dispenser Leaks
FDA (Devices) · 2018-09-26