PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody 50 testsRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630972197), received between Oct 29, 2021 and Oct 29, 2021 — classified as 1 injury.

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

• InjuryOct 29, 2021False Negative Result; False Negative Result

  A CUSTOMER FROM THE UNITED STATES ALLEGED AN IMPACT TO PATIENT TREATMENT BASED ON FALSE NEGATIVE RESULTS FOR A PATIENT SAMPLE STAINED WITH PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL ANTIBODY TEST. THE CUSTOMER REPORTED THAT THE PATIENT UNDERWENT A NEEDLE & SKIN PUNCH BIOPSY IN (B)(6) 021 FOR COLLECTION OF TISSUE SAMPLE FOR TESTING. ON (B)(6) 2021, PATIENT'S PRIMARY BREAST TUMOR SAMPLE WAS TESTED, YIELDING NEGATIVE HER-2 RESULT. THE NEGATIVE RESULTS WERE RELEASED TO THE PATIENT'S TREATING PHYSICIAN. THE PATIENT'S INITIAL DIAGNOSIS WAS REPORTEDLY INVASIVE DUCTAL CARCINOMA AND THE PATHOLOGIST ONSITE STATED THAT THE PATIENT HAD CHEMOTHERAPY WITH PATHOLOGIC COMPLETE RESPONSE, CLINICALLY RESPONDED ON RADIOLOGY. ON (B)(6) 2021, THE PATIENT HAD A DOUBLE MASTECTOMY, INCLUDING LYMPH NODES, RIGHT AXILLARY REGIONAL RESECTIONS. NO RESIDUAL DISEASE WAS DETECTED AFTER MASTECTOMY IN BREAST AND AXILLARY LYMPH NODES. HOWEVER, A REPEAT PET SCAN INDICATED THE PRESENCE OF RESIDUAL LESIONS IN THE AXILLARY. THEREFORE, ON (B)(6) 2021, PATIENT'S BREAST LYMPH NODE SAMPLE WAS TESTED, YIELDING A POSITIVE HER-2 RESULT. THE INITIAL PRIMARY TUMOR SAMPLE WAS THEN REPEAT TESTED, THIS TIME YIELDING A POSITIVE H

  Patient problems: Breast Cancer

  MAUDE report 12724503 ↗