VENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results
Ventana Medical Systems recalled 8,927 VENTANA PD-L1 (SP142) Assay kits worldwide due to light staining that can cause false-negative immunotherapy marker test results affecting cancer treatment decisions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic device with confirmed risk of false-negative results that could directly affect cancer treatment decisions. While no illnesses or injuries have been reported, the hazard is substantiated and significant, fitting the rubric criterion for risk-of-harm products without yet-reported injury.
Plain-English summary
The VENTANA PD-L1 (SP142) Assay is a laboratory diagnostic test that detects PD-L1 protein expression in tissue samples, helping oncologists decide whether immunotherapy is appropriate for cancer patients. Ventana Medical Systems has recalled 8,927 kits due to light staining discovered in internal comparison studies.
Light staining reduces both the staining intensity and the percentage of cells detected as positive. For borderline cases—where the true result sits near the threshold between positive and negative—this reduced staining can cause the test to incorrectly report a negative result, potentially leading to a false-negative PD-L1 determination. This could result in patients not receiving appropriate immunotherapy treatment.
The affected kits have been distributed worldwide, including throughout the United States and multiple international countries. Healthcare providers should contact Ventana Medical Systems or the FDA for guidance on affected lot numbers and for instructions regarding the review of previously reported results from this assay.
No illnesses or injuries have been reported to date. However, results from affected kits, particularly in borderline cases, may not be reliable.
The recalled product
- 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
- Manufacturer
- Ventana Medical Systems, Inc.
- Hazard
- false-negative
- light-staining
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Distributed nationwide across the United States.
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