Ventana Medical Systems Recalls Leaking HPV III Probe Dispensers
Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test 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 where a mechanical defect leads to false negative diagnostic results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ventana Medical Systems Inc is recalling 195 units of the INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295. This product is an immunohistochemistry (IHC) reagent intended for in vitro diagnostic use. The specific lot number is Y19417, and the Unique Device Identifier (UDI) is 4015630972210.
The recall was initiated because the reagent dispensers for horseradish peroxidase (HRP) are leaking and sticking. This mechanical defect can lead to a false negative immunohistochemistry result, which may impact the accuracy of diagnostic testing.
The affected units were distributed worldwide. Healthcare facilities and laboratories that have received this specific lot should stop using the product and contact Ventana Medical Systems for instructions on how to return or dispose of the units.
The recalled product
- Product
- INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 195
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: Y19417
- UDI: 4015630972210
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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