Ventana Medical Systems Recalls ultraView SISH DNP Detection Kit Due to Leaking
Ventana Medical Systems is recalling 96 units of the ultraView SISH DNP Detection Kit because leaking and sticking dispensers may cause false negative IHC results.
What this means for you
Illness, injury, or structural failure has been reported. 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, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Ventana Medical Systems Inc is recalling 96 units of the ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098. The product is an immunohistochemistry (IHC) kit for in vitro diagnostic use. The specific lot number is Y24347 and the UDI is 4015630970384.
The recall was initiated because the horseradish peroxidase (HRP) reagent dispensers are leaking and sticking. This defect may result in a false negative IHC result. The agency has classified this recall as Class I.
The affected units were distributed worldwide. Users of the product should stop using the affected kits and contact Ventana Medical Systems Inc for further instructions.
The recalled product
- Product
- ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 96
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: Y24347
- UDI: 4015630970384
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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