i-STAT hs-TnI cartridge 09P81-25Recalls & reported problems
Abbott Point of Care Inc. · i-STAT hs-TnI cartridge · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10054749003058), received between Jul 28, 2026 and Sep 22, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (13 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Positive Result13
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Chest Pain1
- Chills1
- Cough1
- Fever1
- Limb Pain1
- Muscle Weakness/Atrophy1
- Pneumothorax1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859843 ↗MalfunctionSep 22, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859842 ↗MalfunctionSep 15, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776647 ↗MalfunctionSep 15, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776646 ↗MalfunctionSep 15, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776645 ↗MalfunctionSep 15, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776644 ↗MalfunctionSep 15, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776643 ↗MalfunctionSep 9, 2026False Positive Result
Patient problems: Chills; Fever; Muscle Weakness/Atrophy
MAUDE report 50696482 ↗MalfunctionSep 9, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696481 ↗MalfunctionSep 9, 2026False Positive Result
Patient problems: Cough
MAUDE report 50696480 ↗MalfunctionSep 9, 2026False Positive Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696476 ↗MalfunctionJul 28, 2026False Positive Result
Patient problems: Syncope/Fainting; Unspecified Infection
MAUDE report 50060515 ↗MalfunctionJul 28, 2026False Positive Result
Patient problems: Chest Pain; Limb Pain; Pneumothorax
MAUDE report 50060514 ↗
Other IMMUNOASSAY METHOD, TROPONIN SUBUNIT devices
- i-STAT 03P90-25Abbott Point Of Care Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT474 reports
- Atellica IM TNIH 10997841Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT463 reports
- Access hsTnI B52669Beckman Coulter, Inc. · Immunoassay Method, Troponin Subunit2 recalls170 reports
- i-STAT 06P23-25Abbott Point Of Care Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT195 reports
- VITROS 6802301Ortho Clinical Diagnostics · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall139 reports
- Atellica IM TNIH 10997840Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT166 reports
- Dimension EXL LOCI Troponin I High Sensitive 10471068Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 recall76 reports
- Access AccuTnI+3 A98143Beckman Coulter, Inc. · Immunoassay Method, Troponin Subunit1 death106 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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