StatSensor 1.0 (REF 45335)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00385480453356), received between Jun 22, 2021 and Jun 22, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. A TEST WAS RUN ON THE STATSENSOR METER SERIAL NUMBER (B)(4) WITH TEST STRIP LOT 4920227129, AND THE EGFR WAS RUNNING LOW FOR THE PATIENT. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041582 ↗
• MalfunctionJun 22, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. A TEST WAS RUN ON THE STATSENSOR METER SERIAL NUMBER (B)(4) WITH TEST STRIP LOT 4920227129, AND THE CREATININE WAS READING OVERLY HIGH WITH AN OVERLY LOW EGFR. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041568 ↗

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-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
• 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