HemaPrompt FG HPFGRecalls & reported problems
Aerscher, Inc · HemaPrompt FG Fecal and Gastric Test Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00693501000152), received between May 15, 2026 and May 15, 2026 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Patient problems
- 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.
MalfunctionMay 15, 2026
ALL BOXES OF HEMAPROMPT FG GUAIAC CARDS IN ED WITH LOT NUMBER 307 (WHICH IS OUR CURRENT ONLY SUPPLY) HAVE HAD NUMEROUS FAULTY TESTING CARDS. CONTROL AREA IS NOT DEVELOPING THEREFORE RENDERING THE TEST FAULTY AND UNUSABLE. HAS BEEN REQUIRING UTILIZATION OF MULTIPLE CARDS PER PATIENT SPECIMEN TO FIND ONE IN BATCH THAT DOES PASS CONTROL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183494 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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