StatSensor 1.0 (REF 44052)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00385480440523), received between May 11, 2021 and Dec 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K070068); they may or may not involve this specific model.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Low Test Results; Low Test Results

  THE CUSTOMER REPORTED DISCREPANT CREATININE RESULTS ON A STATSENSOR METER SN (B)(4)WHILE USING STRIPS WITH LOT NUMBER 4921209129. THE RESULTS WERE QUESTIONED AND THE SAMPLES WERE RUN ON A LAB CHEMISTRY ANALYZER WHICH CONFIRMED THE DISCREPANT VALUES. THE PATIENT WAS NOT TREATED BASED OFF OF THE RESULTS FROM THE METER AND THERE WERE NO ADVERSE INTERACTIONS. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117443 ↗
• MalfunctionMay 12, 2021Incorrect Measurement; Low Test Results; Low Readings; Incorrect Measurement; Low Test Results; Low Readings

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING DISCREPANT CREATININE RESULTS USING A STATSENSOR HOSPITAL METER, SERIAL NUMBER (B)(4) AND CREATININE TEST STRIPS LOT 4920177139. IT WAS REPORTED THE PATIENT DISAGREED WITH THE INITIAL RESULTS. WHEN SAMPLES WERE RUN ON A LAB ANALYZER, THE RESULTS DID NOT MATCH THOSE OF THE METER. NO INAPPROPRIATE TREATMENT WAS STARTED AND THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE RESULT. THIS IS REPORT TWO OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812726 ↗
• MalfunctionMay 11, 2021Incorrect Measurement; Low Test Results; Low Readings; Incorrect Measurement; Low Test Results; Low Readings

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING DISCREPANT CREATININE RESULTS USING A STATSENSOR HOSPITAL METER, SERIAL NUMBER (B)(4) AND CREATININE TEST STRIPS LOT 4920177139. IT WAS REPORTED THE PATIENT DISAGREED WITH THE INITIAL RESULTS. TESTING WITH ANOTHER METER SHOWED SIMILAR RESULTS. WHEN SAMPLES WERE RUN ON A LAB ANALYZER, THE RESULTS DID NOT MATCH EITHER OF THE METERS. NO INAPPROPRIATE TREATMENT WAS STARTED AND THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE RESULT. THIS IS REPORT ONE OF TWO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807585 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070068. One submission often covers many models, so check the product and lot details in each record.

• Z-0650-2014 · Oct 10, 2013 · Terminated
  Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Sin
• Z-1472-2008 · Feb 21, 2008 · Terminated
  Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine
• Z-0725-2008 · Nov 2, 2007 · Terminated
  Nova - EZ CHEM Control Solution P/N 9612, Nova Biomedical, Waltham, MA 02454
• Z-0726-2008 · Nov 2, 2007 · Terminated
  Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454
• Z-0724-2008 · Nov 2, 2007 · Terminated
  Nova - EZ CHEM Creatinine Meter: SRS Versions 5.1 and 5.2 P/N 9600, Nova Biomedical, Waltham, MA 02454