Ventana recalls anti-CD10 (SP67) Rabbit Monoclonal Antibody REF 790-4506 due to potential false positives in lab tests. Affected units have specific UDI codes.
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
Ventana is recalling a specific antibody product used in lab testing because it can cause false positive results. This means test results might be inaccurate, which could lead to incorrect diagnoses or treatments.
The antibody may cause high background staining and off-target reactions during lab tests. This can lead to false positive results, potentially causing incorrect conclusions about test samples.
Lab technicians and researchers using this antibody for medical testing. Those who have the specific product code (UDI) are most at risk.
Check for the product code REF: 790-4506 on the label. The unique device identifier (UDI) codes include 04015630972579, J04613, J11853, and other listed codes.
Look for the product code REF: 790-4506 and the unique device identifier (UDI) codes listed in the recall notice.
No, this is a laboratory product used by professionals. The recall is for potential false positives in lab tests, not a safety hazard for end users.
Check the product label for REF: 790-4506 and the specific UDI codes listed in the recall notice.
The recall does not require stopping use; it's for lab testing accuracy. Affected users should check the UDI codes and contact Ventana if needed.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-2644-2024 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-2644-2024 from Ventana. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
