FDA recall Z-2644-2024

Ventana Medical Systems, Inc. · Class II · device

Product

Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

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

Key facts

Status
Ongoing
Initiation date
2024-06-27
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oro Valley, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2644-2024