STAT PROFILE PRIME CCS COMP (REF 52857)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00385480528573), received between Mar 31, 2022 and Apr 5, 2022 — classified as 5 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K141907); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2022Incorrect Measurement; High Test Results; No Apparent Adverse Event; Incorrect Measurement; High Test Results; No Apparent Adverse Event

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING PCO2 RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME CCS COMP ANALYZER WITH SERIAL NUMBER (B)(4). THE USER DID NOT BELIEVE THE RESULTS PRODUCED WERE ACCURATE AND QUESTIONED THE RESULTS BEFORE PROVIDING ANY TREATMENT. THE SAME SAMPLE WAS RUN ACROSS ANOTHER STATPROFILE PRIME PLUS CCS COMP ANALYZER WHICH 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 14014864 ↗
• MalfunctionMar 31, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED DISCREPANT RESULTS ON PRIME ANALYZER (B)(4) FOR PCO2. THE CLINICIAN QUESTIONED THE RESULTS AND RAN THE SAMPLE AGAIN ON A DIFFERENT PRIME ANALYZER. THIS SECOND TEST WAS CLOSER TO THE PATIENT HISTORY AND CENTRAL LAB DATA. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964673 ↗
• MalfunctionMar 31, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT RESULTS ON PRIME ANALYZER (B)(4) FOR PCO2. THE CLINICIAN QUESTIONED THE RESULTS AND RAN THE SAMPLE AGAIN ON A DIFFERENT PRIME ANALYZER. THIS SECOND TEST WAS CLOSER TO THE PATIENT HISTORY AND CENTRAL LAB DATA. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964415 ↗
• MalfunctionMar 31, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT RESULTS ON PRIME ANALYZER P07A17210C FOR PCO2. THE CLINICIAN QUESTIONED THE RESULTS AND RAN THE SAMPLE AGAIN ON A DIFFERENT PRIME ANALYZER. THIS SECOND TEST WAS CLOSER TO THE PATIENT HISTORY AND CENTRAL LAB DATA. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964315 ↗
• MalfunctionMar 31, 2022Low Test Results; Low Test Results

  THE CUSTOMER REPORTED DISCREPANT RESULTS ON PRIME ANALYZER P07A17210C FOR PCO2. THE CLINICIAN QUESTIONED THE RESULTS AND RAN THE SAMPLE AGAIN ON A DIFFERENT PRIME ANALYZER. THIS SECOND TEST WAS CLOSER TO THE PATIENT HISTORY AND CENTRAL LAB DATA. THERE WAS NO PATIENT HARM OR INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964206 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141907. One submission often covers many models, so check the product and lot details in each record.

• Z-2732-2017 · Jun 19, 2017 · Terminated
  Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime C