Severity
Critical
CriticalClass ITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0730-2018) was formally reported on March 7, 2018, with the manufacturer initiating the action on December 19, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Ventana Medical Systems Inc is listed as the recalling firm, operating out of Oro Valley, AZ. Federal records list the affected scope as 72730 units.
The documented reason for this recall is: 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 Hematoxyl… Distribution data in the federal record shows the product reached: 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,…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
72730 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic. Recalled by Ventana Medical Systems Inc. Units affected: 72730 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 7, 2018. Severity: Critical. Recall number: Z-0730-2018.
Where was the recalled product distributed? ▼
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, Uruguay, Peru, Canada, Taiwan, China,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0730-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 7, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.