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STATSTRIP 1.0 (REF 51707)Recalls & reported problems

Nova Biomedical Corporation · StatStrip GLU Meter with Quick Reference Guide Remanufactured · 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 00385480517072), received between Apr 1, 2022 and Apr 1, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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

  • Incorrect, Inadequate or Imprecise Result or Readings1

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.

  • MalfunctionApr 1, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE ED EDUCATOR REPORTED THAT THEY HAD A PEDIATRIC PATIENT WITH QUESTIONABLE NOVA STATSTRIP GLUCOMETER RESULTS. THE TEST WAS RUN MARCH 02ND ON THEIR STATSTRIP METER S/N: (B)(4) USING TEST STRIPS WITH LOT: 0321243249. THE PATIENT WAS IN DIABETIC KETOACIDOSIS AND THEN HAD BLOOD SUGARS IN A LOWER-THAN-EXPECTED RANGE ON ONE OF THE GLUCOMETERS. WHEN THEY TESTED ON AN ALTERNATE GLUCOMETER LATER IN THE EVENING, THE BLOOD SUGAR WAS IN THE RANGE (176) THAT MATCHED THE CLINICAL PICTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13981132 ↗

Other GLUCOSE OXIDASE, GLUCOSE devices

All GLUCOSE OXIDASE, GLUCOSE devices →

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