i-STAT 04P75-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00054749003709), received between Sep 22, 2017 and Jul 11, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(6) WOULD NOT ACTIVATE, AND BATTERIES ARE BECOMING HOT. THERE WAS A SPARK AND SMELL WAS OBSERVED. THE CUSTOMER ALSO STATED USING 9V ALKALINE DURA CELL BATTERIES WHICH ARE NOT RECOMMENDED. CUSTOMER ADVISED BY TS TO USE 9V LITHIUM DISPOSABLE BATTERIES OR 9V NIMH RECHARGEABLE BATTERIES WITH THE I-STAT. THERE WAS NO SMOKE ASSOCIATED WITH THE EVENT. THE PRODUCT WAS REPLACED AT NO CHARGE. 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 A RED FUSED CARRIER WAS BEING USED WITH 9V ALKALINE BATTERS WERE BEING USED AT THE TIME OF THE EVENT. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH, FAILING SAFE. 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 17298005 ↗
• MalfunctionFeb 20, 2019Electrical /Electronic Property Problem; Loose or Intermittent Connection; Device Damaged Prior to Use; Electrical /Electronic Property Problem; Loose or Intermittent Connection; Device Damaged Prior to Use

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER SN (B)(4) DISPLAYED CODE 66 AND 86. CUSTOMER REPORTS WHEN THE BATTERIES WERE REMOVED FROM THE ANALYZER THEY WERE HOT TO TOUCH. THE CUSTOMER ALSO REPORTS THAT WHEN DIFFERENT BATTERIES WERE INSTALLED IN THE ANALYZER, CODE 66 AND 86 STILL PERSIST. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. 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 RECHARGEABLE BATTERIES ((B)(4)) WERE BEING USED AT THE TIME OF THE EVENT. 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 8353418 ↗
• MalfunctionAug 1, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED VISIBLE SMOKE COMING FROM I-STAT1 ANALYZER (B)(4) AFTER REPLACING THE RECHARGEABLE BATTERY . THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER AND RECHARGEABLE BATTERY PACK 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. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. 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 7738306 ↗
• MalfunctionMar 30, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED VISIBLE SMOKE WHEN CHANGING THE BATTERY ON ANALYZER (B)(4). THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE ANALYZER AND RECHARGEABLE BATTERY PACK 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. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED AT THE TIME OF THE EVENT. 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 7385798 ↗
• MalfunctionSep 22, 2017Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  NA.

  Patient problems: No Patient Involvement

  MAUDE report 6888239 ↗

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-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-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-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-1976-2012 · Sep 8, 2011 · Terminated
  i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
• 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-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