i-STAT 04P75-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00054749003716), received between Sep 22, 2017 and Dec 5, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).

13 other recalls cover devices cleared under the same FDA submission (K001387); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON 04-DEC-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT 1 ANALYZER (SN (B)(6)) WAS SWOLLEN AND BURST INSIDE THE BATTERY COMPARTMENT. BUSINESS PARTNER REPLACED THE BATTERY AND BATTERY CARRIER BUT ANALYZER IS NOT ACTIVATING. THE ANALYZER WERE REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. THERE WAS LIMITED INFORMATION AND BATTERY CARRIER INFORMATION WAS NOT PROVIDED AT THE TIME OF THIS REPORT. THERE ARE NO DETAILS SURROUNDING THE EVENT, CONDITION OF THE ANALYZER IN USE, NOR IF THE PRODUCT WAS BEING USED AS INTENDED. THERE ARE NO INJURIES ASSOCIATED WITH THE EVENTS. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266117 ↗
• MalfunctionNov 11, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15779424 ↗
• MalfunctionMay 12, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(4) BECAME HOT TO TOUCH. THE ANALYZER WOULD NOT ACTIVATE AND THE CUSTOMER NOTICED THAT THE BATTERY WAS HOT, SMELLED LIKE AN ELECTRICAL FIRE, AND THE GOLD CHARGING PINS LOOKED BURNT. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT DISPOSABLE LITHIUM BATTERIES IN A RED CARRIER WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND IS BEING RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14381088 ↗
• MalfunctionSep 22, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER (B)(4) WAS WARM TO TOUCH ON THE INITIAL CALL, THAN WHEN TRANSFERRED TO ANOTHER REPRESENTATIVE STATED THAT THE ANALYZER WAS ACTUALLY HOT TO TOUCH. THE CUSTOMER STATES THAT THE I-STAT WAS OPERATING WITH RECHARGEABLE BATTERIES. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

  Patient problems: No Patient Involvement

  MAUDE report 6888219 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001387. One submission often covers many models, so check the product and lot details in each record.

• Z-1973-2012 · Sep 8, 2011 · Terminated
  iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 anal
• Z-1974-2012 · Sep 8, 2011 · Terminated
  i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and
• Z-1975-2012 · Sep 8, 2011 · Terminated
  Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200
• Z-1978-2012 · Sep 8, 2011 · Terminated
  Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, P
• Z-1976-2012 · Sep 8, 2011 · Terminated
  i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
• Z-1977-2012 · Sep 8, 2011 · Terminated
  i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat
• Z-0597-2011 · Sep 20, 2010 · Terminated
  i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2
• Z-0598-2011 · Sep 20, 2010 · Terminated
  Military Kit Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests for sodium, potassium, ionized calcium, hematocrit, p
• Z-2462-2010 · Aug 20, 2010 · Terminated
  GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that i
• Z-1133-2010 · Nov 6, 2009 · Terminated
  Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a
• Z-0865-2010 · Sep 29, 2009 · Terminated
  i-STAT HL7 Interface The HL7 Interface product is an accessory to the analyzer
• Z-0812-2010 · Sep 9, 2009 · Terminated
  i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT t
• Z-2328-2009 · Apr 22, 2009 · Terminated
  Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT tes