FDA Devices recall · Reported March 7, 2018
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
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 CINt…
Ventana Medical Systems Inc recalled ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 052698060… - a critical-severity action.
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 052698060… was recalled by Ventana Medical Systems Inc in March 7, 2018. Reason: Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (par…. Check the official notice for the remedy. Verify recall #Z-0730-2018 with the FDA Devices before acting.
The recall
Ventana Medical Systems Inc issued this critical-severity FDA Devices recall-Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (par….
- Critical
- severity level
- 73K units
- affected scope
- Class I
- classification
- March 7, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0730-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0730-2018 |
| Date reported | March 7, 2018 |
| Date initiated | December 19, 2017 |
| Recalling firm | Ventana Medical Systems Inc |
| Firm location | Oro Valley, AZ |
| Affected scope | 72730 units |
| Distribution | Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0730-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026