Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported September 26, 2018
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ventana Medical Systems Inc recalled CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohisto… - a critical-severity action.
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohisto… was recalled by Ventana Medical Systems Inc in September 26, 2018. Reason: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC re…. Check the official notice for the remedy. Verify recall #Z-3013-2018 with the FDA Devices before acting.
The recall
Ventana Medical Systems Inc issued this critical-severity FDA Devices recall-Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC re….
- Critical
- severity level
- 240 units
- affected scope
- Class I
- classification
- September 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3013-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3013-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on August 2, 2018. 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 240 units.
The documented reason for this recall is: Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur. Distribution data in the federal record shows the product reached: worldwide. 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 - 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 - 40,422 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
240 units
Related Recalls
6
0 from same agency
Product description
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
Reason for recall
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-3013-2018 |
| Date reported | September 26, 2018 |
| Date initiated | August 2, 2018 |
| Recalling firm | Ventana Medical Systems Inc |
| Firm location | Oro Valley, AZ |
| Affected scope | 240 units |
| Distribution | worldwide |
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-3013-2018) 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? ▼
CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.. Recalled by Ventana Medical Systems Inc. Units affected: 240 units.
Why was this product recalled? ▼
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Critical. Recall number: Z-3013-2018.
Where was the recalled product distributed? ▼
Distribution: worldwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3013-2018) 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
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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 September 26, 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.