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.
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Contact the company
📍Recalling firmVentana Medical Systems, Inc.1910 E Innovation Park Dr · Oro Valley, AZ 85755-1962
“Ventana anti-CD10 antibody recall: False positive results risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/54738-ventana-anti-cd10-antibody-recall-false-positive-results-risk. Based on FDA recall #Z-2644-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2644-2024%22&limit=1).
The FDA announced on June 27, 2024, that Ventana Medical Systems, Inc. is recalling its Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody due to a potential for false positive results. The agency classified the recall as Class II.
The antibody may cause high background and off-target staining, which can result in false positive results. The FDA said the recall addresses this potential for inaccurate test outcomes.
Context
GovInfoNow's records show Ventana Medical Systems, Inc. has issued seven other recalls since December 19, 2017. Recent brand recalls include a 2026-04-20 recall for navify Digital Pathology v2.5 Software due to image discrepancies and a 2022-11-18 recall for the PD-L1 (SP142) Assay where light staining may cause false-negative results. Other recent recalls of similar products include the Quidel QuickVue Strep A Test Recall on 2026-04-06, the Immunotech Estrone RIA Kit Recall on 2025-12-15, and the Diagnostica Stago Asserachrom HPIA Kit Recall on 2025-12-15.
How to tell if you have this one
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.
Brand
Ventana
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the product code REF: 790-4506 and the unique device identifier (UDI) codes listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 48 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2644-2024 (June 27, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2644-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.