Ventana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects
Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to potential false negative diagnostic results.
Plain-English summary
Ventana Medical Systems Inc is recalling CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296. The product is used for Immunohistochemistry (IHC) for in vitro diagnostic purposes. The recall involves 1,655 units distributed worldwide.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). This defect may result in a false negative IHC result. The affected lot numbers are Y12992, Y18852, and Y23051, with UDI 4015630972203.
Healthcare facilities and laboratories should stop using the affected product and contact Ventana Medical Systems for instructions on return or replacement. This recall is classified as Class I by the FDA.
The recalled product
- Product
- CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 1,655
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: Y12992
- Y18852
- Y23051
- UDI: 4015630972203
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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