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Ventana Medical Systems, Inc. recalls Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

Recalled August 28, 2024 · FDA recall Z-2644-2024 · Ventana Medical Systems

Hazard
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results. · FDA Class II
Units
22,839 kits
Sold at
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, TX, UT, VA, VT, WA, WI, WV and the countries of Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Albania, Argentina, Armenia, Australia, Azerbaijan, Bahrain, Belarus, Brazil, Cameroon, Chile, China, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, Egypt, El Salvador, Georgia, Ghana, Guatemala, Honduras, Hong Kong, India, Iran, Iraq, Israel, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Malaysia, Mali, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, New Zealand, Nicaragua, Nigeria, North Macedonia, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Taiwan, Tanzania, Thailand, T¿rkiye, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.

Description

Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.

Product
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Manufacturer(s)
Ventana Medical Systems, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov