Ventana Recalls CINtec PLUS Cytology Kits Due to Leaking Reagent Dispensers
Ventana Medical Systems is recalling 18 units of the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences, and the issue is a mechanical defect (leaking/sticking) rather than a direct biological hazard.
Plain-English summary
Ventana Medical Systems Inc is recalling 18 units of the CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, and Roche GMMI 06889549001 in vitro diagnostic. The affected units are identified by UDI 04015630976287 and Lot Numbers Y22162 and Y15546.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers and with Hematoxylin II. These dispensers are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit.
The affected products were distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. Users of these kits should stop using the affected dispensers and contact the manufacturer for further instructions.
The recalled product
- Product
- CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Hazard
- Affected units
- 18
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 04015630976287
- Lot Numbers: Y22162
- Y15546
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 · mechanical defect
See all →- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
- ModerateSurgical driver systems recalled over out of the box driver wobble
FDA (Devices) · 2025-09-03
- HighBeckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation
FDA (Devices) · 2025-03-19
- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- HighVNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
FDA (Devices) · 2025-02-12