PD-L1 IHC 28-8 pharmDx SK005Recalls & reported problems
Agilent Technologies, Inc. · PD-L1 IHC 28-8 pharmDx · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05700571108161), received between Dec 22, 2020 and Dec 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: HEAVY STAINING IN POSITIVE TISSUES AND CONTROLS. CUSTOMER REQUESTED A DIFFERENT LOT FROM THE MANUFACTURER. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11060445 ↗
Other Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 devices
- VENTANA PDL1 SP142 ASSAY 50testsVentana Medical Systems, Inc. · Immunohistochemistry assay, antibody, programmed death-ligand 11 recall0 reports
- PD-L1 IHC 22C3 pharmDx SK006Agilent Technologies, Inc. · Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 11 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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