Stat Profile Prime Plus (REF 57400)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00385480574006), received between Aug 28, 2019 and Mar 11, 2026 — classified as 1 death, 49 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (16 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 18, 2023Open, Classified

   Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.

   Z-0207-2024 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Failure to Prime

  PER CUSTOMER: "I AM WRITING TO REPORT THAT OUR NOVA STAT PROFILE PRIME PLUS WAS COMPLETELY NONFUNCTIONAL TODAY, WHICH SIGNIFICANTLY IMPACTED PATIENT TESTING AND WORKFLOW IN OUR LABORATORY. THIS DOWNTIME DIRECTLY AFFECTED PATIENT CARE. WE HAD A STAT PATIENT WITH SUSPECTED HYPERKALEMIA, AND WE WERE UNABLE TO PROVIDE CRITICAL POTASSIUM RESULTS TO THE PROVIDER DUE TO THE INSTRUMENT FAILURE. THIS SITUATION POSED A SERIOUS RISK TO TIMELY CLINICAL DECISION-MAKING." A FOLLOW UP WITH THE CUSTOMER INDICATED THE ANALYZER HAD BEEN DOWN ALL DAY AND AFTER CONSUMABLES WERE REPLACED THE ANALYZER HAS BEEN BUSY PRIMING/CALIBRATING AND MOST OF THE TEST ARE LOCKED OUT. THE AUDIT LOG INDICATED SLOPE ERRORS ON SEVERAL PARAMETERS.

  Patient problems: Hyperkalemia

  MAUDE report 24570256 ↗
• MalfunctionFeb 12, 2026Failure to Calibrate; Calibration Problem

  CONSUMER REPORTED THAT THEY HAVE BEEN HAVING ISSUES WITH THE ANALYZER STAYING CALIBRATED FOR PO2 AND HAVE CONSISTENTLY NEEDED TO REPLACE THE CONSUMABLES.THE CONSUMER REQUESTED SERVICE DUE TO INCONSISTENCY WITH CALIBRATION.

  Patient problems: Insufficient Information; Ventilator Dependent

  MAUDE report 24321484 ↗
• MalfunctionDec 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2025 THE CUSTOMER RAN PATIENT SAMPLES FOR PH AND HCO3 (BICARBONATE). THEY BELIEVED THE RESULTS THEY RECEIVED WERE INACCURATE AND RETESTED ANOTHER SAMPLE ON A DIFFERENT ANALYZER (ISTAT). THERE WAS SIGNIFICANT DISCREPANCY BETWEEN THE 2 ANALYZERS. IT IS UNCLEAR HOW MUCH TIME HAD PASSED BETWEEN THE RETESTING OF THE SAMPLE. ALTHOUGH THERE WAS NO REPORTED TREATMENT TO THE PATIENT BASED ON THE ALLEGED INACCURATE RESULTS, THE CUSTOMER CLAIMED THAT THERE COULD HAVE BEEN AN ADVERSE EVENT HAD THEY TREATED BASED ON THOSE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830129 ↗
• MalfunctionMay 2, 2025Low Test Results; Low Test Results

  SODIUM RESULT INCOMPATIBLE WITH THE PATIENT'S CLINICAL DATA.

  Patient problems: Heart Failure/Congestive Heart Failure; Renal Failure

  MAUDE report 21952903 ↗
• MalfunctionNov 15, 2022Low Readings; Low Readings

  CUSTOMER REPORTS DISCREPANCIES IN HB RESULTS FOR ONE PATIENT.

  Patient problems: Pulmonary Dysfunction

  MAUDE report 15799839 ↗
• MalfunctionJul 15, 2022No Apparent Adverse Event; No Apparent Adverse Event

  COMPLAINANT REPORTED SUSPECT ERROR PROBLEMS OVER THE WEEKEND OF (B)(6) 2022 WHICH RESULTED IN A DELAY OF CARE FOR A PATIENT IN THE NEONATAL UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15033007 ↗
• MalfunctionJul 7, 2022Incorrect Measurement; Incorrect Measurement

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF BICARBONATE (HCO3) AND BASE EXCESS OF BLOOD (BE-B) RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME PLUS ANALYZER WITH SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED BUT THE CLINICIAN QUESTIONED THE ACCURACY OF THESE WHEN COMPARED TO THE CLINICAL PRESENTATION OF THE PATIENT. AN ADDITIONAL SAMPLE FROM THE PATIENT WAS RUN USING THE REFERENCE EPOC ANALYZER WHICH CONFIRMED THE INITIAL RESULTS WERE INACCURATE. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14944310 ↗
• MalfunctionJul 7, 2022Incorrect Measurement; Incorrect Measurement

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF SODIUM, POTASSIUM, CHLORIDE, AND BLOOD UREA NITROGEN (BUN) RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME PLUS ANALYZER WITH SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED BUT THE CLINICIAN QUESTIONED THE ACCURACY OF THESE WHEN COMPARED TO THE CLINICAL PRESENTATION OF THE PATIENT. AN ADDITIONAL SAMPLE FROM THE PATIENT WAS RUN USING THE REFERENCE ANALYZER BECKMAN AU WHICH CONFIRMED THE INITIAL RESULTS WERE INACCURATE. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14944290 ↗
• MalfunctionMar 31, 2022Smoking; Smoking

  CUSTOMER REPORTED THAT WHEN THE PRIME PLUS ANALYZER WAS PLUGGED IN THERE WAS A BURNING SMELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965970 ↗
• MalfunctionMar 31, 2022Smoking; Smoking

  CUSTOMER REPORTED THAT WHEN THE PRIME PLUS ANALYZER WAS PLUGGED IN THERE WAS A BURNING SMELL AND THE SCREEN REMAINED BLACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965873 ↗
• MalfunctionMar 2, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  PRIME PLUS REPORTED HIGHER HEMATOCRIT RESULTS AND DOES NOT CORRELATE WELL WHEN COMPARED TO THE HEMOGLOBIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656430 ↗
• MalfunctionMar 2, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  PRIME PLUS REPORTED HIGHER HEMATOCRIT RESULTS AND DOES NOT CORRELATE WELL WHEN COMPARED TO THE HEMOGLOBIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656294 ↗
• MalfunctionMar 2, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  PRIME PLUS REPORTED HIGHER HEMATOCRIT RESULTS AND DOES NOT CORRELATE WELL WHEN COMPARED TO THE HEMOGLOBIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656279 ↗
• MalfunctionMar 2, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  PRIME PLUS REPORTED HIGHER HEMATOCRIT RESULTS AND DOES NOT CORRELATE WELL WHEN COMPARED TO THE HEMOGLOBIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656247 ↗
• MalfunctionMar 2, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  PRIME PLUS REPORTED HIGHER HEMATOCRIT RESULTS AND DOES NOT CORRELATE WELL WHEN COMPARED TO THE HEMOGLOBIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656186 ↗
• MalfunctionFeb 23, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTS THAT THE NOVA PRIME PLUS ANALYZER SN (B)(4) RETURNED A LOWER CREATININE RESULT THAN A REFERENCE ANALYZER. THE PATIENT WAS GIVEN CONTRAST BASED OFF OF THIS RESULT FOR A CT SCAN.

  Patient problems: Insufficient Information

  MAUDE report 13587092 ↗
• MalfunctionJan 19, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER INDICATED THAT THEIR PRIME PLUS ANALYZER SERIAL NUMBER PP1120040C REPORTED PATIENT RESULTS FOR SODIUM AND POTASSIUM WITH A SIGNIFICANT DIFFERENCE TO LABORATORY VALUES FROM SAME SAMPLING TIME. CUSTOMER CONFIRMED THAT THE PATIENT RESULTS WERE NOT USED FOR MEDICAL DECISIONS AND THERE WAS NO PATIENT INJURY, HARM OR ADDITIONAL TREATMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13289443 ↗
• DeathNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING MISSING CO-OXIMETRY RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME PLUS ANALYZER WITH SERIAL NUMBER (B)(4). IT WAS REPORTED THE PATIENT ARRIVED INTUBATED AND WAS PRESUMED TO BE INTOXICATED LEADING TO SEVERE METHEMOGLOBINEMIA. THE PRIME PLUS ANALYZER DID NOT PRODUCE CO-OXIMETRY RESULTS WHEN RUNNING A SAMPLE AND INSTEAD DISPLAYED A "RESULTS SUSPECT" MESSAGE. THIS SAMPLE WAS RUN ON AN ADDITIONAL ANALYZER WHICH CONFIRMED THE "RESULTS SUSPECT". AFTER THREE ATTEMPTS AT RUNNING A SAMPLE, A METHEMOGLOBIN VALUE OF 55% WAS RECEIVED. WITHOUT CONFIRMATION OF THE DIAGNOSIS, THE PATIENT WAS TREATED BASED ON CLINICAL PRESENTATION. THE PATIENT LATER WENT INTO CARDIAC ARREST AND DID NOT RECOVER AFTER CARDIOPULMONARY RESUSCITATION.

  Patient problems: Cardiac Arrest; Loss of consciousness

  MAUDE report 12843935 ↗
• MalfunctionNov 7, 2021Low Test Results; Low Test Results

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A SITUATION WHERE AN INACCURATE RESULT FOR SODIUM (NA) WAS RECEIVED WHILE USING A STATPROFILE PRIME PLUS ANALYZER, (B)(4). THE NURSE QUESTIONED THE RESULTS AS THEY DID NOT FIT THE PATIENT'S CLINICAL PRESENTATION. ADDITIONAL SAMPLES WERE RUN ACROSS AN ADDITIONAL ANALYZER AND CONFIRMED THE INITIAL RESULTS WERE INCORRECT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759394 ↗
• MalfunctionNov 7, 2021High Test Results; High Test Results

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A SITUATION WHERE AN INACCURATE RESULT FOR SODIUM (NA) WAS RECEIVED WHILE USING A STATPROFILE PRIME PLUS ANALYZER, (B)(4). THE NURSE QUESTIONED THE RESULTS AS THEY DID NOT FIT THE PATIENT'S CLINICAL PRESENTATION. ADDITIONAL SAMPLES WERE RUN ACROSS OTHER ANALYZERS AND CONFIRMED THE INITIAL RESULTS WERE INCORRECT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759051 ↗
• MalfunctionSep 28, 2021Smoking; Insufficient Device Problem Information; Smoking; Insufficient Device Problem Information

  NOVA BIOMEDICAL CORPORATE WAS MADE AWARE OF A POTENTIAL PRODUCT MALFUNCTION USING A STATPROFILE PRIME PLUS BENCHTOP ANALYZER, SERIAL NUMBER (B)(4). IT WAS REPORTED THE ANALYZER WAS PRODUCING A BURING SMELL AND SMOKE WAS COMING FROM THE MACHINE. THE ANALYZER WAS IMMEDIATELY TAKEN OUT OF SERVICE AND REMOVED FROM THE FACILITY. THERE WAS NO IMPACT ON PATIENT OR USER SAFETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541450 ↗
• MalfunctionAug 24, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER INDICATED THAT THEIR PRIME PLUS ANALYZER SERIAL NUMBER: (B)(4) REPORTED DISCREPANT PCO2 MEASUREMENT, HCO3 AND CL ARE BOTH HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362110 ↗
• MalfunctionAug 24, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER INDICATED THAT THEIR PRIME PLUS ANALYZER SERIAL NUMBER: (B)(4) REPORTED DISCREPANT PCO2 MEASUREMENT, HCO3 AND CL ARE BOTH HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12361052 ↗
• MalfunctionAug 24, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER INDICATED THAT THEIR PRIME PLUS ANALYZER SERIAL NUMBER: (B)(4) REPORTED DISCREPANT PCO2 MEASUREMENT, HCO3 AND CL ARE BOTH HIGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360107 ↗
• MalfunctionJul 8, 2021Imprecise or Erratic Results; Imprecise or Erratic Results

  THE CUSTOMER REPORTED DISCREPANT PATIENT RESULTS. A TEST WAS RUN ON JUNE 11TH ON THE PRIME PLUS SN: (B)(4) AND REPORTED HIGH CREATININE RESULTS UTILIZING BUN/ CREAT CARD LOT: 21130038. THE PATIENTS DID NOT HAVE THE SCHEDULED PROCEDURES BASED ON THE RESULTS SINCE THE VALUES WERE QUESTIONED BY THE PHYSICIAN. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136057 ↗