# FDA recall Z-0907-2023

> **Ventana Medical Systems, Inc.** · Class II · device recall initiated 2022-11-18.

## Product

VENTANA PD-L1 (SP142)    VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001  VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001  VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001

## Reason for recall

Internal comparison studies revealed unacceptable, light staining.  Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.

## Distribution

Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO,CT, DC, DE, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, and WI. The countries of Canada, Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom, Albania, Armenia, Bangladesh, Belarus, Costa Rica, Cote d'Ivoire, Cuba, Dominican Republic, Egypt, El Salvador, Ghana, Guatemala, Iran, Israel, Jordan, Kenya, Kosovo, Kuwait, Lebanon, Mauritius, Morocco, Myanmar, Nigeria, North Macedonia, Oman, Panama, Philippines, Russian Fed., Saudi Arabia, Serbia, South Africa, Tanzania, Turkey, Turkmenistan and United Arab Emirates.  Update (04-Jan-2023): Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Hong Kong, Honduras, Ind

## Key facts

- **Recall number:** Z-0907-2023
- **Recalling firm:** Ventana Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-18
- **Report date:** 2023-01-18

- **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-0907-2023

## Citation

> AI Analytics. FDA recall Z-0907-2023. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0907-2023. Source: US FDA. Licensed CC0.

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