Ventana Anti-Pan Keratin Antibody Recalled for Leaking and Sticking Dispensers
Ventana Medical Systems is recalling 354 units of Anti-Pan Keratin Primary Antibody 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 354 units of Anti-Pan Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135. The product is used for Immunohistochemistry (IHC) for in vitro diagnostic use. The recall affects Lot Number Y21610 with UDI 4015630971572, which was distributed worldwide.
The recall is being issued because the reagent dispensers for horseradish peroxidase (HRP) are leaking and sticking. This malfunction may result in a false negative IHC result.
No specific instructions for consumers are provided in the source text, but the product is intended for in vitro diagnostic use.
The recalled product
- Product
- ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 354
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: Y21610
- UDI: 4015630971572
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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