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BOND™ PA0151Recalls & reported problems

Leica Biosystems Newcastle Ltd · Estrogen Receptor Clone 6F11 (ER 6F11) Mouse Monoclonal antibody is intended for laboratory use to qualitatively identify estrogen receptor (ER) antigen in sections of formalin fixed, paraffin embedded breast cancer tissue by immunohistochemistry methods. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055331304575), received between Dec 26, 2018 and Dec 26, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Improper or Incorrect Procedure or Method1
  • Insufficient Device Problem Information1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 26, 2018Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

    LEICA BIOSYSTEMS (B)(4) LTD RECEIVED A COMPLAINT FOR CONTRADICTORY RESULTS BEING ACHIEVED WITH LEICA PA0151 ON THE SAME PATIENT CASE. THE COMPLAINT STATES THAT IT IS POSSIBLE THAT INCORRECT TREATMENT HAS BEEN ADMINISTERED AS A RESULT. THE PATIENT HAS RECEIVED HERCEPTIN TREATMENT. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8196243 ↗

Other Immunohistochemistry Antibody Assay, Estrogen Receptor devices

All Immunohistochemistry Antibody Assay, Estrogen Receptor devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.