Ventana CONFIRM anti-Estrogen Receptor Antibody Recalled for Dispenser Defects
Ventana Medical Systems is recalling CONFIRM anti-Estrogen Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (false negative diagnostic results) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ventana Medical Systems Inc is recalling CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325. The product is intended for Immunohistochemistry (IHC) for in vitro diagnostic use.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. This defect may result in a false negative IHC result.
The recall involves 1,719 units distributed worldwide. Affected lot numbers are Y18586 and Y24472, with UDI 4015630972234. Users should stop using the affected units and contact the manufacturer for instructions.
The recalled product
- Product
- CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 1,719
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: Y18586
- Y24472
- UDI: 4015630972234
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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