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

Recall date

June 27, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2644-2024

FDA classification

Class II

Brand / firm

Ventana Medical Systems, Inc.

Sold / distributed

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, Belg…

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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