i-STAT 03P75-55Recalls & reported problems
Abbott Point Of Care Inc. · i-Stat 1 Wireless Analyzer · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00054749003402), received between Nov 6, 2017 and Nov 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
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
Device problems
- Electrical /Electronic Property Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 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 SN (B)(4) WOULD NOT ACTIVATE. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNED FOR ROUTINE FAILURE ANALYSIS. THE ANALYZER WAS RECEIVED ON 10/16/2017 AND ON 10/24/2017 DURING FAILURE ANALYSIS IT WAS NOTED THAT CAPACITOR C13 ON MAIN PCBA WAS BURNT. THE CUSTOMER RETURNED THE ANALYZER WITH GREEN NON-FUSED BATTERY CARRIER. THE CUSTOMER WAS NEVER ISSUED BATTERY CARRIER LETTER # APOC30AUG2010 - SEPTEMBER 2011. IT IS UNKNOWN HOW THE CUSTOMER OBTAINED A GREEN NON-FUSED BATTERY CARRIER SINCE THE CUSTOMER HAS ONLY BEEN AN I-STAT USER SINCE 2016. THE ANALYZER WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2016 WITH A RED FUSED BATTERY CARRIER. THE CUSTOMER SEARCHED THE FACILITY AND STATED THAT THEY ONLY HAVE RED-FUSED BATTERY CARRIERS ON SITE AS OF (B)(6) 2017. 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 DOES STATE THAT 9 VOLT BATTERIES WERE BEING USED. THEREFORE THE ANALYZER IS LIKELY TO BECOME HOT TO TO
Patient problems: No Patient Involvement
MAUDE report 7004139 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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