Mono Mo A-Hu MUC5AC Cl CLH2 M7316Recalls & reported problems
Agilent Technologies Singapore Pte Ltd · Monoclonal Mouse Anti-Human MUC5AC Clone CLH2 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05700572034544), received between Jul 20, 2022 and Oct 2, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (3 reports).
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
- Failure to Power Up3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 2, 2023Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED THAT THE LAMP ON HIS OLYMPUS HALOGEN LIGHT SOURCE WAS NOT POWERING ON DURING PREPARATION FOR A DIAGNOSTIC PROCEDURE. ACCORDING TO THE INITIAL REPORTER, A SPARE BULB WAS TRIED, AND STILL NO SUCCESS. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17851119 ↗MalfunctionJul 21, 2022Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED THAT HIS OLYMPUS HALOGEN LIGHT SOURCE'S LAMP WAS NOT LIGHTING DURING USE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15074674 ↗MalfunctionJul 20, 2022Failure to Power Up; Failure to Power Up
THE CUSTOMER REPORTED THAT HIS OLYMPUS HALOGEN LIGHT SOURCE WAS NOT LIGHTING DURING USE. ACCORDING TO THE INITIAL REPORTER, HE TRIED CHANGING OUT THE LAMP, BUT THE FAILURE PERSISTED. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15064792 ↗
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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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