CONFIRM antiEstrogen Receptor ER SP1 Rabbit Monoclonal Primary Antibody 50 testsRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630972241), received between Jan 10, 2024 and Jan 12, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2026Product Quality Problem; 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 RESULTS FOR PATIENT SAMPLES TESTED ON A BENCHMARK ULTRA STAINER MODULE. IT WAS REPORTED THAT RESTAINING OF LOW-EXPRESSING TUMORS WITH A NEW LOT OF ER SP1 ANTIBODY HAS LED TO NOTABLE CLINICAL DIFFERENCES IN SCORING. INITIALLY, 6 CASES WERE TESTED, WHICH RESULTED IN 3 PATIENTS BEING SCORED AS 2/3 DUE TO THE LOW EXPRESSION OF ER SP1 ANTIBODY; HOWEVER, ON RETESTING SHOWED A SCORE OF 4/5. FURTHER RESTAINING OF 33 CASES ORIGINALLY SCORED 0-5 IDENTIFIED, 5 CASES WERE FOUND TO BE ELIGIBLE FOR TREATMENT. ONE PATIENT REPORTEDLY RECEIVED UNNECESSARY CHEMOTHERAPY. THERE IS NO INFORMATION ABOUT ANY SIGNIFICANT DELETERIOUS EFFECTS ASSOCIATED WITH THE RECEIPT OF CHEMOTHERAPY. FURTHER INFORMATION RELATED TO THE PATIENT, INCLUDING CURRENT CONDITION, ANY DELETERIOUS EFFECTS, AND DIAGNOSTIC DECISIONS BASED ON THE ASSAY RESULTS, HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24038601 ↗
• MalfunctionJan 10, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER ALLEGES THEY RECEIVED A NEGATIVE RESULT FOR A REGIONAL QUALITY CONTROL SAMPLE TESTED WITH CONFIRM ANTI-ESTROGEN RECEPTOR ER SP1 ON A BENCHMARK ULTRA STAINER MODULE. A BREAST CANCER TISSUE SAMPLE USED AS QUALITY CONTROL FOR THE CUSTOMER'S REGION WAS TESTED USING THE CONFIRM ANTI-ESTROGEN RECEPTOR ER SP1 AND THE RESULT WAS NEGATIVE (SLIGHTLY LESS THAN 1%). THE RESULT WAS NOT REPORTED TO THE PATIENT. COMPETITOR PLATFORMS USING OTHER CLONES HAD POSITIVE RESULTS FOR THE SAME CONTROL SAMPLES WITH ESTROGEN RECEPTOR VALUES CLOSE TO 90 %.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486047 ↗