i-STAT 03P93-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10054749000217), received between Oct 12, 2018 and Nov 13, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K053597); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2019False Negative Result; False Negative Result

  NA.

  Patient problems: Congestive Heart Failure; Edema

  MAUDE report 9315263 ↗
• MalfunctionOct 12, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT BNP CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT TROPONIN RESULT ON A (B)(6) FEMALE PATIENT WITH CHF, COPD, CHRONIC KIDNEY DISEASE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE. METHOD: I-STAT, DATE: (B)(6) 2018, RESULT: 1116; LAB, (B)(6) 2018, 406. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Congestive Heart Failure; Renal Failure; Respiratory Distress

  MAUDE report 7962086 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053597. One submission often covers many models, so check the product and lot details in each record.

• Z-2170-2012 · Feb 1, 2012 · Terminated
  i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole b
• Z-0319-2011 · Jan 1, 2008 · Terminated
  i-STAT BNP cartridge Abbott Point of Care, Princeton, NJ 08540