Ventana ultraView Universal Alkaline Phosphatase Red Detection Kit Recalled
Ventana Medical Systems is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit 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 (medical diagnostic device) where a defect may lead to incorrect clinical results (false negatives), but the source text does not report any actual injuries, illnesses, or deaths, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ventana Medical Systems Inc is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501. The product is an immunohistochemistry (IHC) kit intended for in vitro diagnostic use. The affected lots are Y15071, Y18053, and Y22469, with UDI 4015630972258. The recall covers units distributed worldwide.
The recall was initiated because the horseradish peroxidase (HRP) reagent dispensers are leaking and sticking. This mechanical defect may result in false negative immunohistochemistry test results. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and laboratories that have purchased or received these specific lots should stop using the affected kits and contact Ventana Medical Systems Inc for further instructions on returns or replacements. Consumers should not attempt to use these professional diagnostic kits at home.
The recalled product
- Product
- ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 8,211
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 (4)
- Lot Numbers: Y15071
- Y18053
- Y22469
- UDI: 4015630972258
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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