NOVA MAXRecalls & reported problems across all models
Nova Biomedical Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of NOVA MAX by Nova Biomedical Corporation in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2017 and Apr 14, 2021 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).
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
Most reported NOVA MAX problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Insufficient Device Problem Information9
- High Readings4
- Improper or Incorrect Procedure or Method4
- Incorrect Or Inadequate Test Results4
- Incorrect, Inadequate or Imprecise Result or Readings3
- No Display/Image3
- High Test Results2
Patient problems
- Hyperglycemia14
- Hypoglycemia11
- No Known Impact Or Consequence To Patient10
- No Information6
- No Consequences Or Impact To Patient4
- Loss of consciousness2
- Patient Problem/Medical Problem2
- Sweating2
NOVA MAX models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Nova Max PlusNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)28 reports
- NOVA MAX LinkGLUCOSE OXIDASE, GLUCOSE14 reports
- NOVA MAX GLUSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER4 reports
- Nova Max PlusSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER2 reports
Recent NOVA MAX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2021Imprecision; No Apparent Adverse Event; Imprecision; No Apparent Adverse Event
COMPLAINANT CALLED INTO REPORT A HIGH BLOOD GLUCOSE READING. SUBSEQUENT TO TROUBLESHOOTING WITH NOVA MAX GLUCOSE CONTROLS AND TO BACK TO BACK BLOOD GLUCOSE VALUES. THE DIFFERENCE WAS DETERMINED TO BE CLINICALLY SIGNIFIGANT.
Patient problems: Hyperglycemia
MAUDE report 11665973 ↗MalfunctionSep 24, 2020Imprecision; Imprecision
COMPLAINANT REPORTED THAT SHE IS CONCERNED ABOUT A DISCREPANCY USING HER NOVA MAX PLUS BLOOD GLUCOSE MONITOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10581731 ↗MalfunctionJun 15, 2020No Display/Image; Missing Test Results; No Display/Image; Missing Test Results
THE COMPLAINANT STATED THE LAST DIGIT IS MISSING FROM THE RESULTS SEGMENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10153120 ↗MalfunctionJun 2, 2020Display Difficult to Read; Display Difficult to Read; Device Markings/Labelling Problem
THE CONSUMER CALLED IN REPORTING HER METER IS MISSING DIGITS. THE CONSUMER STATED THE FIRST DIGIT OF THE RESULTS IS MISSING AND ALL FOUR DIGITS OF THE YEAR ARE MISSING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10111588 ↗MalfunctionApr 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results
THE CONSUMER STATED HE IS CONCERNED ABOUT HIGH BLOOD GLUCOSE (BG) READINGS. THE CONSUMER STATED HE WAS FEELING A "BIT LOW", ACCORDING TO THE CONSUMER, HE FELT "WEAK AND TIRED" WHEN HE TESTED AT 11:48PM BEFORE GOING TO BED, THEREFORE HE GAVE HIMSELF AT LEAST "2-3 MORE UNITS OF INSULIN" AFTER HE TESTED. THE CONSUMER ADMINISTERED A TOTAL OF 7.4MM UNITS OF INSULIN. THE CONSUMER DOES NOT RECALL THE DOSAGE OF INSULIN SUGGESTED BY HIS PUMP FOR THIS READING. THE CONSUMER DID NOT SAY WHAT HIS READING SHOULD HAVE BEEN INSTEAD OF THE 309 BG RESULT. ACCORDING TO THE CONSUMER, HE TREATS HIMSELF BASED ON HOW HE FEELS, THE CONSUMER KNOWS WHEN TO ADMINISTER MORE OR LESS INSULIN. CONSUMER'S HCP IS AWARE AND "IS OKAY WITH CONSUMER ADJUSTING HIS INSULIN INTAKE SINCE HE KNOWS HIS SYMPTOMS WELL AND ACTS ACCORDINGLY" THE CONSUMER WENT TO BED A LITTLE AFTER 11:48PM AND WOKE UP AT 2:46AM FEELING CONFUSED, WEAK AND HAD BLURRED VISION. THE CONSUMER IMMEDIATELY TESTED HIS BG AND GOT THE RESULT OF 178, THE CONSUMER DID NOT TAKE INSULIN, HE INSTEAD ATE CHEESE WITH CRACKERS AND MILK. THE CONSUMER "RELAXED FOR A FEW MINUTES AND FELT HIMSELF RECOVERING". THE CONSUMER WENT TO BACK TO SLEEP ONCE HE STARTED FEELING
Patient problems: Hypoglycemia; Patient Problem/Medical Problem
MAUDE report 9922025 ↗MalfunctionMar 24, 2020Low Readings
COMPLAINANT REPORTED A 'LOW' BLOOD GLUCOSE READING. DID NOT TREAT BASED ON RESULT(S) OBTAINED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9871968 ↗MalfunctionFeb 11, 2020High Readings
COMPLAINANT CALLED TO REPORT "HIGH BG (BLOOD GLUCOSE) READINGS". THE COMPLAINANT STATED SHE CORRECTED HER INSULIN INTAKE FOR SOME BLOOD GLUCOSE READINGS. THE COMPLAINANT DOES NOT REMEMBER FOR WHICH BLOOD GLUCOSE READING SHE CORRECTED HER INSULIN INTAKE. SHE FURTHER STATES SHE CORRECTED HER INSULIN "MULTIPLE TIMES THROUGHOUT THE DAY". AFTER TESTING HERSELF MANY TIMES SHE DECIDED TO GO TO THE ER DUE TO HER HIGH BLOOD GLUCOSE READINGS AND SYMPTOMS. COMPLAINANT STATED SHE NOTICED SHE WAS HAVING "SYMPTOMS RELATED TO LOW BLOOD GLUCOSE SUGAR" WHILE SHE WAS READING HIGH. SHE STATED SHE "FELT DIZZY, CONFUSED, HAD A HEADACHE AND FELT TIRED". COMPLAINANT ARRIVED AT THE HOSPITAL "APPROXIMATELY" 1PM, THE NURSE DISCONNECTED HER INSULIN PUMP. THE COMPLAINANT WAS MAINLY UNDER OBSERVATION AT THE HOSPITAL. NO MEDICATION WAS GIVEN, ONLY FOOD AND JUICE. WHILE AT THE HOSPITAL HER HUSBAND BROUGHT A NEW VIAL OF NOVA MAX GLUCOSE TEST STRIPS. COMPLAINANT DID NOT HAVE THE LOT NUMBER OF THE NEW VIAL. THE COMPLAINANT TESTED HER BG USING HOSPITALS UNK METER AGAINST HER NOVA MAX LINK (NML) METER USING THE NEW VIAL OF NOVA MAX GLUCOSE TEST STRIPS. HOSPITAL'S UNK METER RESULT WAS 84 AND NML METER READ 86. THE COM
Patient problems: Hypoglycemia; Patient Problem/Medical Problem
MAUDE report 9693915 ↗MalfunctionDec 24, 2019No Apparent Adverse Event; High Test Results; No Apparent Adverse Event
COMPLAINANT STATED HE IS NOT TESTING CONSISTENTLY DUE TO HIS HIGH BLOOD GLUCOSE READINGS. HE STATED THAT ON (B)(6) 2019 HIS HCP CHANGED HIS INSULIN TYPE AND INCREASED THE DOSE. ON THIS DAY HE STATED HE "PASSED OUT" FOR A FEW MINUTES. AFTER PASSING OUT, THE COMPLAINANT "GOT UP, ATE SOMETHING AND STARTED WATCHING TV". HE REPORTS HE CONTACTED HIS HCP IN REGARD TO THE ISSUE.
Patient problems: Fainting; No Consequences Or Impact To Patient
MAUDE report 9516333 ↗MalfunctionDec 5, 2019No Display/Image; No Display/Image
THE COMPLAINANT REPORTED E1 (SYSTEM HARDWARE ERROR) - NOT REPORTABLE FAILURE, AS SOON AS SHE INSERTED THE TEST STRIP INTO THE METER.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9417786 ↗MalfunctionOct 23, 2019No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem
THE COMPLAINANT REPORTED THE METER DISPLAY IS MISSING THE LAST DIGIT FROM HIS TEST RESULT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9226055 ↗MalfunctionJun 18, 2019High Readings
COMPLAINANT REPORTS THAT HE TOOK HIMSELF TO THE HOSPITAL ER BECAUSE HE WAS CONCERNED WITH HIGH BLOOD GLUCOSE READINGS.
Patient problems: Hyperglycemia
MAUDE report 8708623 ↗MalfunctionMar 8, 2019Device Displays Incorrect Message
COMPLAINANT STATED HIS METER SCREEN ONLY DISPLAYS 2 DIGITS OF HIS BLOOD GLUCOSE READING (1ST AND 2ND DIGITS ONLY).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8404941 ↗MalfunctionJan 29, 2019Incorrect, Inadequate or Imprecise Result or Readings
COMPLAINANT WAS CONCERNED ABOUT THE DIFFERENCE IN HER BG READINGS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8286062 ↗MalfunctionOct 22, 2018Adverse Event Without Identified Device or Use Problem
THE COMPLAINANT STATED THAT "BECAUSE OF HER 209MG/DL READING SHE TOOK AN EXTRA DOSE OF GENEVA ALONG WITH NORMAL PILL DOSES". SHE THEN REPORTED THAT SHE WENT FOOD SHOPPING AND FELT "LOW" SHE ATE A CHOCOLATE CANDY BAR AND FELT BETTER.
Patient problems: Hyperglycemia; Hypoglycemia; Overdose
MAUDE report 7991849 ↗MalfunctionOct 22, 2018Improper or Incorrect Procedure or Method; High Readings
A NURSE CALLED IN ON BEHALF OF COMPLAINANT REPORTING BLOOD GLUCOSE READINGS OF 'HI' (METER WILL DISPLAY HI WHEN GLUCOSE SAMPLE VALUE IS ABOVE 600MG/DL). AT 2:40AM COMPLAINANT STATED SHE WOKE UP BECAUSE SHE "WAS FEELING COLD, SWEATY AND SHAKY" SHE THEN DRANK SOME ORANGE JUICE DUE TO HER SYMPTOMS AND WENT BACK TO BED.
Patient problems: Hypothermia; Shaking/Tremors; Sweating
MAUDE report 7991459 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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