Recall Z-2644-2024— Ventana Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ventana Medical Systems, Inc., initiated 2024-06-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD. Reason: Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results..
- Recalling firm
- Ventana Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-06-27
- Firm location
- Oro Valley, AZ, United States
Product description
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Reason for recall
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.