CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody 250 testsRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630972234), received between Dec 18, 2025 and Feb 17, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 2, 2018Class ITerminated

   Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.

   Z-3007-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026False Negative Result

  THERE WAS AN ALLEGATION OF DISCREPANT NEGATIVE RESULTS WITH THE CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY ASSAY FOR 2 PATIENT SAMPLES TESTED ON A BENCHMARK ULTRA SYSTEM. FOR PATIENT 1, THE TUMOR TISSUE FROM THE BIOPSY WAS NEGATIVE. THE SAME TISSUE BLOCK WAS SENT TO AN EXTERNAL LABORATORY, WHERE THE TUMOR WAS IDENTIFIED AS POSITIVE (50%, POSITIVITY SCORE) ON A BOND SYSTEM. ON (B)(6) 2025, THE SAME TISSUE BLOCK WAS SENT TO ANOTHER LABORATORY, WHERE THE TUMOR WAS EVALUATED AS POSITIVE. ON 17-NOV-2025: FOR PATIENT 2, THE TUMOR WAS EVALUATED AS NEGATIVE. EXTERNAL VERIFICATION ON A BOND SYSTEM USING THE SAME TISSUE BLOCK REVEALED POSITIVE STAINING (40% POSITIVITY SCORE). ON (B)(6) 2025 THE SAME TISSUE BLOCK WAS SENT TO ANOTHER LABORATORY, WHERE THE TUMOR WAS EVALUATED AS POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24365196 ↗
• InjuryDec 18, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS WITH THE CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY ASSAY FOR A PATIENT SAMPLE TESTED ON A BENCHMARK ULTRA STAINER MODULE. THE INITIAL RESULT WAS ER NEGATIVE. THE REPEAT RESULT WAS MODERATE ER POSITIVE. THE PATIENT WAS DIAGNOSED AS TRIPLE NEGATIVE BREAST CANCER (TNBC). WITH THE UPDATED ER-POSITIVE RESULT, IT IS REPORTED THAT THE PATIENT WOULD BE ELIGIBLE FOR HORMONE THERAPY. DESPITE MULTIPLE ATTEMPTS, NO FURTHER INFORMATION RELATED TO THE PATIENT, INCLUDING CURRENT CONDITION, ANY DELETERIOUS EFFECTS, AND DIAGNOSTIC DECISIONS BASED ON THE ASSAY RESULTS, COULD BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 23838220 ↗
• InjuryDec 18, 2025False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings; False Negative Result; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS WITH THE CONFIRM ANTI-ESTROGEN RECEPTOR (ER) (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY ASSAY FOR A PATIENT SAMPLE TESTED ON A BENCHMARK ULTRA STAINER MODULE. THE INITIAL RESULT WAS ER NEGATIVE. THE REPEAT RESULT WAS ER-POSITIVE (1+, 60% POSITIVE TUMOR CELLS). THE PATIENT WAS DIAGNOSED AS TRIPLE NEGATIVE BREAST CANCER (TNBC) AND RECEIVED 7 CYCLES OF CHEMOTHERAPY (NAB-PACLITAXEL) AND PORT SURGERY. WITH THE UPDATED ER-POSITIVE RESULT, IT IS REPORTED THAT THE PATIENT MAY HAVE BENEFITED FROM ENDOCRINE THERAPY ALONE. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT WAS PROGESTERONE RECEPTOR (PR) NEGATIVE AND HER2 LOW 2+. DESPITE MULTIPLE ATTEMPTS, NO FURTHER INFORMATION RELATED TO THE PATIENT, INCLUDING CURRENT CONDITION, ANY DELETERIOUS EFFECTS, AND DIAGNOSTIC DECISIONS BASED ON THE ASSAY RESULTS, COULD BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 23838213 ↗