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.
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.
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.
The assay shows light staining that can reduce staining intensity and percent positivity. This may cause the test to incorrectly show negative results when the patient actually has cancer, potentially delaying treatment.
Pathologists and labs using the recalled PD-L1 (SP142) assays for cancer testing are most at risk. Patients receiving results from these assays could be affected if the test gives false negatives.
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.
Look for UDI-DI codes 04015630967155, 07613336106709, or 04015630976591 on the product packaging.
Internal comparison studies showed unacceptable light staining that can reduce staining intensity and percent positivity, potentially causing false-negative results in cancer testing.
The assay might incorrectly show a negative result when the patient actually has cancer, which could delay treatment.
Check for UDI-DI codes 04015630967155, 07613336106709, or 04015630976591 on the product packaging.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0907-2023 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0907-2023 from Ventana. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
