Lower risk Medical device recall · FDA · Published November 18, 2022

Ventana PD-L1 (SP142) Assay Recall: Light Staining May Cause False-Negative Results

Ventana Medical Systems recalls PD-L1 (SP142) assays due to light staining causing potential false-negative results in cancer testing. Affected units have specific UDI-DI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0907-2023Medical device Ventana ›

Lower-risk 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.

Take action

Contact the company

Recalling firmVentana Medical Systems, Inc.1910 E Innovation Park Dr · Oro Valley, AZ 85755-1962

✎ GovInfoNow plain-language explainer

Ventana Medical Systems has recalled certain PD-L1 (SP142) cancer testing assays because light staining can lead to false-negative results. This means the test might incorrectly show a negative result when the patient actually has cancer, potentially delaying treatment. Read more at govinfonow.com/recall/59316-ventana-pd-l1-sp142-assay-recall-light-staining-may-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/59316-ventana-pd-l1-sp142-assay-recall-light-staining-may-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0907-2023

Cite this page

“Ventana PD-L1 (SP142) Assay Recall: Light Staining May Cause False-Negative Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59316-ventana-pd-l1-sp142-assay-recall-light-staining-may-cause. Based on FDA recall #Z-0907-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0907-2023%22&limit=1).

The FDA announced on 2022-11-18 that Ventana Medical Systems, Inc. is recalling VENTANA PD-L1 (SP142) Assays due to light staining that may cause false-negative results. The recall affects 8,927 kits distributed worldwide.

How to tell if you have it

Brand: Ventana
Product: VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001
Product: VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 08008540001
Product: VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 07011571001
UDI-DI Code: 04015630967155
Lot codes: F30596, G27114, G31438, H03958, H13049, H35110, J12769, J18775, J25361
UDI-DI Code: 07613336106709
Lot codes: F31427, G06715, G16831, G24564, H00001, H07164, H15132, H18578, J00572, J01568, J14244, J20989
Lot codes: H08373
UDI-DI Code: 04015630976591
Lot codes: H17865, H30521, H35111, J11932, J20132

The hazard

Internal comparison studies revealed unacceptable light staining that affects the borderline of positive versus negative test results. This reduction in staining intensity and percent positivity could potentially lead to a false-negative PD-L1 result.

Context

GovInfoNow's records show Ventana Medical Systems, Inc. has 7 other recalls on record since 2017-12-19. Other recent recalls of similar products include Ventana navify Digital Pathology v2.5 Software Image Discrepancy Recall (2026-04-20), Ventana anti-CD10 antibody recall (2024-06-27), and Ventana HE : Fluid Leak Risk Could Cause Fire in Lab Equipment (2022-06-01). Other recent recalls of similar products include Hologic Aptima HPV Assay Kit Recall (2026-02-18), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), and Diagnostica Stago Asserachrom HPIA Kit Recall (2025-12-15).

How to tell if you have this one

Check for the UDI-DI codes: 04015630967155, 07613336106709, or 04015630976591 on the product packaging. The product names include VENTANA PD-L1 (SP142) Assay (Class III, US IVD) or similar.

Brand
Ventana
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for UDI-DI codes 04015630967155, 07613336106709, or 04015630976591 on the product packaging.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

FDA 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.…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Nov 18, 2022Firm started the recall
Jan 6, 2023FDA classified it Class II
Jan 18, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/59316-ventana-pd-l1-sp142-assay-recall-light-staining-may-cause">Ventana PD-L1 (SP142) Assay Recall: Light Staining May Cause False-Negative Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0907-2023 (November 18, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0907-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.