STATSTRIPRecalls & reported problems across all models
Nova Biomedical Corporation · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one STATSTRIP model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 113
- Deaths reported
- 6
- Injuries reported
- 1
- Recalls
- 1
We found 9 models of STATSTRIP by Nova Biomedical Corporation in the FDA's device registry (GUDID). Together they are named in 113 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2017 and Sep 25, 2026 — classified as 6 deaths, 1 injury, 106 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (34 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
STATSTRIP recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 29, 2026Class IOpen, Classified
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current test. When this defect occurs and the operator accepts the incorrectly displayed patient information without recognizing the mismatch, the current patient's glucose result will be incorrectly assigned to the previous patient's medical record and transmitted to the data management system (DMS), and the current patient's medical record will not receive a result, leaving their glucose status unrecorded and their clinical management without the information needed to guide treatment decisions. The previous patient, whose medical record now contains a glucose result that does not belong to them, may receive inappropriate clinical intervention based on that erroneous result, particularly in critically ill patients, neonates, and infants who cannot communicate symptoms or self-treat. The defect also affects QC barcode scanning: if a QC scan triggers the same retention behavior, QC results may be attributed to an incorrect identifier or QC tests may fail without the user recognizing the underlying cause. This defect does not affect the analytical accuracy of glucose measurements.
Z-3128-2026 · Root cause: Software design · Recall details · FDA record ↗
Most reported STATSTRIP problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings34
- Computer Software Problem18
- Patient Data Problem15
- Failure to Sense7
- Imprecise or Erratic Results6
- High Test Results5
- Low Test Results5
- Output Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- Insufficient Information20
- No Known Impact Or Consequence To Patient18
- No Consequences Or Impact To Patient6
- No Information5
- Hypoglycemia4
- Hyperglycemia2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
STATSTRIP models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- StatStrip 63685Prescription use blood glucose meter for near-patient testing1 recall3 deaths33 reports
- STATSTRIP 1.86Prescription use blood glucose meter for near-patient testing1 death33 reports
- StatStrip GLU Test StripGLUCOSE OXIDASE, GLUCOSE2 deaths29 reports
- STATSTRIP 1.75Prescription use blood glucose meter for near-patient testing12 reports
- StatStrip 1.0Single (specified) analyte controls (assayed and unassayed)2 reports
- StatStrip 1.0GLUCOSE OXIDASE, GLUCOSE1 report
- STATSTRIP 1.0ACID, LACTIC, ENZYMATIC METHOD1 report
- STATSTRIP 1.0GLUCOSE OXIDASE, GLUCOSE1 report
- STATSTRIP 1.75Prescription use blood glucose meter for near-patient testing1 report
Recent STATSTRIP adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026High Test Results
A number of glucose tests were performed on a newborn patient. The Nova StatStrip values obtained were consistently higher than those obtained using other test methods.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897042 ↗MalfunctionSep 25, 2026High Test Results
A number of glucose tests were performed on a newborn patient. The Nova StatStrip values obtained were consistently higher than those obtained using other test methods.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896787 ↗MalfunctionSep 25, 2026High Test Results
A number of glucose tests were performed on a newborn patient. The Nova StatStrip values obtained were consistently higher than those obtained using other test methods.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896640 ↗MalfunctionSep 23, 2026Computer Software Problem
Consumer reported results going to incorrect chart.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867194 ↗MalfunctionSep 23, 2026Computer Software Problem
Consumer reported results went to the wrong patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867193 ↗MalfunctionSep 23, 2026Computer Software Problem
Consumer reported the wrong account number going to a different patient after scanning and running the test.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867192 ↗MalfunctionSep 23, 2026Computer Software Problem
Consumer reported results going to incorrect chart.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867191 ↗MalfunctionSep 23, 2026Computer Software Problem
Consumer reported results going into incorrect chart.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867190 ↗MalfunctionSep 23, 2026Computer Software Problem
The consumer reported patient results transmitted to another chart.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867189 ↗MalfunctionSep 23, 2026Computer Software Problem
Consumer reported results going to incorrect chart.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867188 ↗MalfunctionSep 23, 2026Computer Software Problem
Consumer reported an incident of the wrong account number going to a different patient after scanning and running the test.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867187 ↗MalfunctionSep 22, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859368 ↗MalfunctionSep 22, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859070 ↗MalfunctionSep 22, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858156 ↗MalfunctionSep 22, 2026Computer Software Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857458 ↗
Other Nova Biomedical Corporation products
All Nova Biomedical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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