STAT PROFILE Prime CCS Comp (REF 42033)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00385480420334), received between Oct 4, 2021 and Oct 4, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Calibrate” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Failure to Calibrate; Failure to Calibrate

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING THE UNCALIBRATION OF THE BLOOD GAS PARAMETERS WHILE USING A STATPROFILE PRIME CCS COMP ANALYZER WITH THE SENSOR CARD LOT 21085061. IT WAS REPORTED THE UNCALIBRATION CAUSED A DELAY IN REPORTING THE PATIENT'S RESULTS. THERE WAS NOT REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568631 ↗
• MalfunctionOct 4, 2021Failure to Calibrate; Failure to Calibrate

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING THE UNCALIBRATION OF THE PCO2 AND CL PARAMETERS WHILE USING A STATPROFILE PRIME CCS COMP ANALYZER WITH THE SENSOR CARD LOT 21088010. IT WAS REPORTED THE UNCALIBRATION CAUSED A DELAY IN REPORTING THE PATIENT'S RESULTS. THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY DUE TO THE UNRELIABILITY OF THE TESTING RESULTS. THERE WAS NO PATIENT HARM REPORTED DUE TO THE ANALYZER SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568619 ↗
• MalfunctionOct 4, 2021Failure to Calibrate; Failure to Calibrate

  NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING THE UNCALIBRATION OF THE PCO2 PARAMETER WHILE USING A STATPROFILE PRIME CCS COMP ANALYZER WITH THE SENSOR CARD LOT 21123005. IT WAS REPORTED THE UNCALIBRATION CAUSED A DELAY IN REPORTING THE PATIENT'S RESULTS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568618 ↗

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