Ventana Medical Systems, Inc.: Device Recall
Recall #Z-2644-2024 · 06/27/2024
Recall Details
- Recall Number
- Z-2644-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ventana Medical Systems, Inc.
- Status
- Ongoing
- Date Initiated
- 06/27/2024
- Location
- Oro Valley, AZ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,839 kits
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.
Product Description
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Distribution Pattern
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.