VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 07709374001 VENTANA PD-L1 (SP142) Assay…
Medical device recall Z-0907-2023. Published in FDA’s Enforcement Report on Jan 18, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 18, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 36 states named
- 8,927 kits how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
8,927 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI Code: 04015630967155 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 F30596 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G27114 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G31438 VENTANA PD-L1…
Every code shown here, 1,955 characters
UDI-DI Code: 04015630967155 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 F30596 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G27114 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 G31438 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H03958 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H13049 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 H35110 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J12769 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J18775 VENTANA PD-L1 (SP142) Assay (Class III, US IVD) 7709374001 J25361 UDI-DI Code: 07613336106709 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 F31427 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G06715 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G16831 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 G24564 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H00001 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H07164 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H15132 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H18578 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 H23050 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J00572 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J01568 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J14244 VENTANA PD-L1 (SP142) Assay (CE IVD Predictive) 8008540001 J20989 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H08373 UDI-DI Code: 04015630976591 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H17865 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H30521 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 H35111 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J11932 VENTANA PD-L1 (SP142) IHC Assay (CE IVD Analytical) 7011571001 J20132
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, Indonesia, India, Japan, Korea, Mexico, Malaysia, New Zealand, Peru, Pakistan, Paraguay, Singapore, Thailand, Taiwan, Uruguay and Vietnam.
The states and territories these words name
36 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 18, 2022.
- FDA classified it on Jan 6, 2023.
- FDA’s Enforcement Report published it on Jan 18, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ventana Medical Systems, Inc., of Oro Valley, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.