STATSTRIP 1.75 (REF 53399)Recalls & reported problems
Nova Biomedical Corporation · Statstrip Glucose Meter with Battery and Quick Reference Guide Remanufactured · Class 2
All models of STATSTRIP (9)
Data updated Oct 16, 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 00385480533997), received between Nov 15, 2018 and Nov 15, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “High Test Results” (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 16, 2026.
Most reported problems
Device problems
- High Test Results1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 15, 2018High Test Results
CUSTOMER REPORTED THAT PATIENT GLUCOSE RESULTS FROM THE STATSTRIP METER APPEARED TO BE INCONSISTENT AND HIGHER THAN EXPECTED. THE OPERATOR THEN USED A SECOND METER AND RECOVERED LOWER RESULTS MORE IN LINE WITH WHAT WAS EXPECTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8073618 ↗
Other Prescription use blood glucose meter for near-patient testing devices
- StatStrip 63685Nova Biomedical Corporation · Prescription use blood glucose meter for near-patient testing1 recall3 deaths33 reports
- STATSTRIP 1.86Nova Biomedical Corporation · Prescription use blood glucose meter for near-patient testing1 death33 reports
- STATSTRIP 1.75Nova Biomedical Corporation · Prescription use blood glucose meter for near-patient testing12 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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