STAT PROFILE PRIME CSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00385480536561), received between May 14, 2020 and May 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

• MalfunctionMay 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020 A CUSTOMER REPORTED TO NOVA BIOMEDICAL THAT A WHOLE BLOOD CAPILLARY SAMPLE PRODUCED DISCREPANT PO2 AND PCO2 RESULTS USING A PRIME CCS ANALYZER, SERIAL NUMBER (B)(4). NO ADVERSE EVENT OR HARM TO PATIENT REPORTED. ON (B)(6) 2020 A FIELD SERVICE SPECIALISTS (FSS) WAS DISPATCHED TO THE SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10057351 ↗

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