i-STAT 04P75-03Recalls & reported problems
Abbott Point Of Care Inc. · i-STAT 1 Wireless · Class 2
Data updated Oct 16, 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 00054749005529), received between Feb 1, 2022 and Feb 1, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ON 25-JAN-2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED OBSERVING SMOKE COMING FROM THE COMPARTMENT OF I-STAT ANALYZER (B)(4) DURING OPERATION. THE PRODUCT DID NOT BECOME HOT TO THE TOUCH. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES REPORTED. 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. THE ANALYZER WAS OPERATING ON RECHARGEABLE BATTERIES AT THE TIME OF THE EVENT. AT THIS TIME THERE IS NO REASON TO BELIEVE PRODUCT WILL BECOME HOT TO THE TOUCH. THE PRODUCT WAS REPLACED AND RETURNING 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 13415716 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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