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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Ventana Medical Systems, Inc.: Rabbit Monoclonal Antibody Recalled for Potential False Positive Results

Agency Publication Date: August 16, 2024
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Summary

Ventana Medical Systems, Inc. is recalling approximately 22,839 kits of the Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody. The recall was initiated because the product may cause high background and off-target staining during laboratory testing. This defect can lead to false positive results, meaning a test might incorrectly indicate the presence of a condition or substance when it is not actually there. These antibodies are primarily used in clinical laboratories and medical diagnostic settings.

Risk

The potential for high background and off-target staining significantly increases the risk of false positive diagnostic results. This can lead to incorrect medical diagnoses, potentially causing patients to receive unnecessary or inappropriate treatments based on flawed laboratory data.

What You Should Do

  1. Identify if your facility possesses the Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody (REF: 790-4506, IVD).
  2. Check the product packaging for UDI 04015630972579 and any of the following lot codes: J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, or M00669.
  3. If you have an affected product, contact your laboratory director or healthcare provider to discuss the need for re-evaluating diagnostic tests performed with these specific lots.
  4. Contact Ventana Medical Systems, Inc. at their Oro Valley, Arizona location (1910 E Innovation Park Dr, Oro Valley, AZ 85755) for further technical instructions and details on product replacement.
  5. Call the FDA's consumer line at 1-888-463-6332 for additional questions regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification via letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund or replacement.

Affected Products

Product: Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody (22,839 kits)
Model / REF:
REF: 790-4506
UDI: 04015630972579
Lot Numbers:
J04613
J11853
J17541
J25047
J30286
K00982
K06239
K09880
K14266
K19784
K26461
M00669

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94985
Status: Active
Manufacturer: Ventana Medical Systems, Inc.
Sold By: Medical laboratories; Hospitals; Diagnostic centers
Manufactured In: United States
Units Affected: 22,839 kits
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.