STAT PROFILE PRIME CCS (REF 55263)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00385480552639), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Calibrate” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 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 CALIBRATION FAILURES OF THE PARAMETER WHILE USING A STATPROFILE PRIME CCS ANALYZER WITH THE SENSOR CARD LOT 21049017. IT WAS REPORTED THE CALIBRATION DELAYS PREVENT SAMPLES FROM BEING RUN WHICH CAUSES A DELAY IN PATIENT RESULTS. THERE WAS NOT REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568622 ↗

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