i-STAT 04P75-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00054749003907), received between Jul 27, 2018 and Jul 27, 2018 — 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 27, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  ON (B)(6) 2018, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED A RATTLING NOISE ON I-STAT 1 ANALYZER SN# (B)(4). THE ANALYZER WAS RETURNED WITH NO REPORTS OF SMOKE OR HEAT RELATED EVENTS. ON (B)(6) 2018 DURING FAILURE ANALYSIS A BURNT C13 CAPACITOR WAS DISCOVERED. THE CUSTOMER DID NOT PROVIDE BATTERY CARRIER OR POWER SOURCE AT THE TIME OF THE CALL. UPON SEVERAL ATTEMPTS THE INFORMATION WAS STILL NOT AVAILABLE. SHIPPING RECORDS SHOWS THAT THE ANALYZER WAS SHIPPED ON (B)(6) 2005 PRIOR TO THE RELEASE OF FUSED BATTERY CARRIERS IN 2011. SHIPPING RECORDS SHOW THAT THE CUSTOMER HAS NOT PURCHASED FUSED-BATTERIES, RED FUSED BATTERY CARRIERS, NOR RECHARGEABLE BATTERIES. THE CUSTOMER WAS SENT THE PRODUCT ACTION INFORMATION BUT DID NOT RESPOND TO THE CORRESPONDENCE REGARDING THE ACTION. AT THIS TIME, IT IS UNKNOWN BUT ASSUMED THAT THE CUSTOMER COULD BE USING GREEN NON-FUSED BATTERY CARRIERS WHICH ARE OBSOLETE AND HAVE BEEN REMOVED FROM THE FIELD. THE CUSTOMER IS NOT RESPONDING TO REQUEST FOR INFORMATION. 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 COMPA

  Patient problems: No Patient Involvement

  MAUDE report 7727235 ↗

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-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-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-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-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-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-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