# FDA recall Z-2644-2024

> **Ventana Medical Systems, Inc.** · Class II · device recall initiated 2024-06-27.

## 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

- **Recall number:** Z-2644-2024
- **Recalling firm:** Ventana Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-2644-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2644-2024. Source: US FDA. Licensed CC0.

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