Home › Ventana Medical Systems, Inc. › VENTANA PD-L1 (SP263) Assay
VENTANA PD-L1 (SP263) Assay
Ventana Medical Systems, Inc. · Model 50 test · UDI-DI 04015630972784
PLS
Prescription
0
510(k) clearances
35
Adverse events
2
Recalls
4
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-18 | Ventana Medical Systems, Inc. | 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 |
| 2018-02-02 | Dako North America Inc. | To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.