Medical Device Recall: Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Ventana Medical Systems, Inc. · June 27, 2024
Reason for Recall
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
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, 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.
States Affected
NATIONWIDE
Quantity Affected
22,839 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2644-2024
Status: ongoing
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