Ventana Medical Systems Inc VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model Number: 790-2991, Lot number: 680957, in vitro diagnostic.
Brand
Ventana Medical Systems Inc
Lot Codes / Batch Numbers
Lot number: 680957
Products Sold
Lot number: 680957
Ventana Medical Systems Inc is recalling VENTANA PATHWAY anti-HER-2/neu (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (PATHWAY HER2 (4B5)); Model due to Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect result: Light staining inconsistencies with lot number 680957 of the Ventana PATHWAY HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.
Recommended Action
Per FDA guidance
The recall was initiated on 09/17/2009 with Ventana Medical Systems forwarding Urgent Voluntary Medical Device Recall letters to all the affected customers advising them to discontinue the use of lot number 680957 and have their laboratory retest with product from a different lot of PATHWAY HER2 (4B5) any breast cases scored as 0, 1+, or 2+ that were not reflexed to an approved in situ hybridization (ISH) method. Customers were also instructed to contact Ventana Customer Support at 1-800-227-2155 and select 1 for Technical Support to speak to a Customer Support agent who will work with then to replace or credit any product from this specific lot number.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026