Ventana Medical Systems Recalls NEXES VEN IVIEW DAB DET KT JPN-US EXPORT
Ventana Medical Systems is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT in vitro diagnostic 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 source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Ventana Medical Systems Inc is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic kits. The recall involves 3,122 units with UDI 04015630970254 and Lot Number Y15392. The products were distributed worldwide, including the US nationwide and various international locations.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. These dispensers are part of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit, and are also associated with Hematoxylin II. The agency has classified this as a Class I recall.
Healthcare facilities and users of these in vitro diagnostic kits should stop using the affected units and contact Ventana Medical Systems Inc for further instructions on the recall process.
The recalled product
- Product
- NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 3,122
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 (2)
- UDI 04015630970254
- Lot Number: Y15392
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 NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects
FDA (Devices) · 2018-09-26
- SevereVentana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana ISH iView Blue Detection Kit Recalled for Leaking Dispensers
FDA (Devices) · 2018-09-26
- SevereVentana Medical Systems Recalls ultraView SISH DNP Detection Kit Due to Leaking
FDA (Devices) · 2018-09-26