Ventana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks
Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers 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 (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 VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015. This product is an immunohistochemistry (IHC) reagent used for in vitro diagnostic purposes.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). This defect may result in false negative IHC results. The affected units are distributed worldwide, with a total of 2,753 units involved. The specific lot numbers are Y12986, Y16448, Y24119, and Y16912Z, with UDI 4015630970018.
Healthcare facilities and laboratories should stop using the affected lots and contact Ventana Medical Systems for further instructions or replacement.
The recalled product
- Product
- VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 2,753
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 (5)
- Lot Numbers: Y12986
- Y16448
- Y24119
- Y16912Z
- UDI: 4015630970018
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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