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PD-L1 IHC 22C3 pharmDx SK006Recalls & reported problems

Agilent Technologies, Inc. · PD-L1 IHC 22C3 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 05700571107300), received between Mar 9, 2021 and Mar 9, 2021 — 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.

  • MalfunctionMar 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    SPECIFICALLY, THE NON-SPECIFIC STAINING WAS SEEN AS NUCLEAR STAINING ON NEGATIVE CONTROL REAGENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11449029 ↗

Other Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 devices

All Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 devices →

Sources and updates

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