Poly Rb A-Hu c-erbB-2 Oncoprotein A0485Recalls & reported problems
Agilent Technologies Singapore Pte Ltd · Polyclonal Rabbit Anti-Human c-erbB-2 Oncoprotein · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 05700572515456), received between Sep 20, 2024 and Sep 20, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “False Positive 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Insufficient Information1
- 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.
InjurySep 20, 2024False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings
THE UNITED STATES OF AMERICA CUSTOMER REPORTED INCONSISTENT RESULTS WITH THE HER2 ANTIBODY. THE CUSTOMER WAS GATHERING BREAST STATS FOR A MARCH 2024 QUALITY ASSESSMENT (QA) WHEN IT WAS NOTED THE CASES HAD AN INCREASE IN THE NUMBER OF EQUIVOCAL RESULTS. THE CUSTOMER NOTED THEY RAN OUT OF THE INITIAL LOT OF HER2 ANTIBODY QUICKER THAN ANTICIPATED WHICH LED TO DOUBTS ON HOW THE TECHS HANDLED AND/OR DILUTED THE ANTIBODY. THEY WERE ONLY ABLE TO MAKE 2 VIALS INSTEAD OF 4. THE CUSTOMER RE-TESTED THESE CASES IN MAY 2024 WITH A NEW LOT NUMBER OF HER2 AND THEY DETERMINED THE PREVIOUS CASES WEREN'T SCORING THE SAME AS WHEN THEY WERE INITIALLY TESTED. THE CUSTOMER DECIDED TO REVIEW ALL HER2 CASES PERFORMED FROM (B)(6) 2024 TO (B)(6) 2024. ANY THAT SCORED 1+ OR 3+ WERE SENT OUT TO ANOTHER LAB FOR IHC W/REFLEX TO FISH. AS A RESULT, THE CUSTOMER SENT OUT 70 CASES FOR COMPARATIVE TESTING. THE CUSTOMER PROVIDED THE RESULTS OF THE 70 CASES SENT FOR COMPARATIVE TESTING AND AFTER REVIEW WITH AN AGILENT PATHOLOGIST, WHILE IT'S UNKNOWN IF A PATIENT RECEIVED ANY TREATMENT AS A RESULT OF THE ORIGINAL SCORING, IT WAS DETERMINED THERE WERE 14 CASES IN WHICH A PATIENT MORE THAN LIKELY RECEIVED THE DRUG HERCEP
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20272455 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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