FDA Device recall Z-2644-2024
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD by Ventana Medical Systems, citing their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2644-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-27 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ventana Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | UDI: 04015630972579/J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, and M00669 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2644-2024%22
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