Ventana Basal Cell IHC Reagent Recall Due to Dispenser Defects
Ventana Medical Systems is recalling 75 units of Basal Cell IHC reagents due to leaking and sticking dispensers that may cause false negative 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 75 units of the VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010. This product is an immunohistochemistry (IHC) reagent intended for in vitro diagnostic use. The affected units are identified by Lot Number Y20881 and UDI 4015630984534.
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.
The affected products were distributed worldwide. Users of this product should stop using the affected units and contact Ventana Medical Systems Inc for further instructions.
The recalled product
- Product
- VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 75
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: Y20881
- UDI: 4015630984534
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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