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StatSensor/StatStrip 1.75 (REF 53400)Recalls & reported problems

Nova Biomedical Corporation · StatStrip StatSensor Docking Station · Class 2

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 00385480534000), received between May 5, 2021 and May 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Overheating of Device1

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 5, 2021Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE STATSTRIP WIRELESS METER (1.86) S/N: (B)(4) HAD BEEN SITTING IN THE DOCKING STATION S/N:(B)(4), WHILE STILL WORKING, IT SMELLS LIKE SMOKE. THE CUSTOMER DISCONTINUE USE OF THE METER. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REPORTED. THE METER AND DOCKING STATION WAS RETURNED FOR EVALUATION. THIS IS REPORT 1 OF 2.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11778716 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.