Ventana Medical Systems Recalls Leaking CINtec p16 Histology Reagent Dispensers
Ventana Medical Systems is recalling 240 units of CINtec p16 Histology reagent dispensers due to leaking and sticking issues that 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur."
Plain-English summary
Ventana Medical Systems Inc is recalling 240 units of CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713. This product is an immunohistochemistry (IHC) reagent intended for in vitro diagnostic use. The recall affects Lot Numbers Y16507 and Y23040, with UDI 4015630984398. The product was distributed worldwide.
The recall was initiated because the reagent dispensers for horseradish peroxidase (HRP) are leaking and sticking. This mechanical defect may result in false negative IHC results, which could impact diagnostic accuracy.
Healthcare facilities and laboratories that have received these specific lot numbers should stop using the affected dispensers and contact Ventana Medical Systems Inc for further instructions on return or replacement.
The recalled product
- Product
- CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 240
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: Y16507
- Y23040
- UDI: 4015630984398
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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