i-STAT 04P75-35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00054749003747), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT1 ANALYZER (B)(4) WOULD NOT TURN ON. CUSTOMER REPORTS THAT THE BATTERIES WERE CHANGED WITH NO IMPROVEMENT. THE ANALYZER, BATTERIES AND CARRIER WERE HOT TO THE TOUCH WHEN THE BATTERIES WERE TAKEN OUT. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THE PRODUCT 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 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 8817571 ↗

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