Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2644-2024

June 27, 2024

Class II

Product summary

Firm
Ventana Medical Systems, Inc.
Event
Event 94985
Status
Ongoing
Classification
Class II
Quantity
22,839 kits
Official record key
device-enforcement:Z-2644-2024

Official wording

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

Code information: UDI: 04015630972579/J04613, J11853, J17541, J25047, J30286, K00982, K06239, K09880, K14266, K19784, K26461, and M00669

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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