Ventana Recalls CINtec p16 Histology Reagent Due to Dispenser Defects
Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
Ventana Medical Systems Inc is recalling 468 units of CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713. This product is an immunohistochemistry (IHC) reagent intended for in vitro diagnostic use. The recall affects Lot Numbers Y13547 and Y19158, with UDI 4015630970469. The products were distributed worldwide.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). These mechanical defects may result in false negative IHC results. The FDA has classified this as a Class I recall, which is the most serious type of recall.
Healthcare facilities and laboratories that have purchased or received these specific lots should stop using the product immediately. Users should contact Ventana Medical Systems Inc for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 468
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)
- Lot Numbers: Y13547
- Y19158
- UDI: 4015630970469
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 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.
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