Ventana Recalls CINtec Histology Reagents Due to Dispenser Defects
Ventana Medical Systems is recalling 120 units of CINtec Histology reagents worldwide 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 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 120 units of CINtec Histology (250) reagents, Catalog Number 06680011001, model 725-4793. These products are used for immunohistochemistry (IHC) in vitro diagnostic testing. The recall covers Lot Number Y23135 and UDI 4015630970476, which were distributed worldwide.
The recall is being conducted because the horseradish peroxidase (HRP) reagent dispensers are leaking and sticking. This defect may result in false negative immunohistochemistry test results.
Healthcare facilities and laboratories that have received these specific units should stop using the affected reagents and contact Ventana Medical Systems for further instructions.
The recalled product
- Product
- CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 120
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 (2)
- Lot Number: Y23135
- UDI: 4015630970476
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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