Alere Triage® 98100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00893038002326), received between Oct 11, 2017 and Dec 13, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED A DISCORDANT D-DIMER RESULT WITH 1 PATIENT SAMPLE WHILE RUNNING A WHOLE BLOOD TO PLASMA CORRELATION STUDY. TRIAGE D-DIMER: WHOLE BLOOD: 215NG/ML; PLASMA: 448NG/ML. PATIENT SAMPLE RESULTED ON STAGO WITH A D-DIMER OF 0.62MG/ML FEU. CUSTOMER STATED STAGO RESULTS WOULD HAVE BEEN WHAT WAS USED BY THE PHYSICIAN. FACILITY TRIAGE D-DIMER CUT-OFF = 400NG/ML, FACILITY STAGO D-DIMER CUT-OFF = 0.50MG/ML FEU. CUSTOMER COULD NOT PROVIDE DIAGNOSIS INFORMATION FOR THE PATIENT BUT STATED THE PATIENT "PRESENTED WITH DIZZINESS, NAUSEA AND PLEURISY, ANXIETY AND DEPRESSION".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8162942 ↗
• MalfunctionSep 6, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VARIABILITY BETWEEN RESULTS PRODUCED ON THE TRIAGE D-DIMER SYSTEM. ON (B)(6) 2018 A PATIENT PRESENTED TO THE CUSTOMER SITE WITH LOCALIZED EDEMA. PATIENT SAMPLE WAS TESTED ON TRIAGE PLATFORM AND PRODUCED D-DIMER RESULTS OF 455NG/ML, 205NG/ML, 233NG/ML, 307NG/ML AND 445NG/ML. THE SPECIFIC TIME OF TESTING WAS NOT PROVIDED BUT CUSTOMER STATED TESTING WAS ALL DONE ON THE SAME DAY WITH THE SAME DRAW. CUSTOMER INDICATED THE RESULT OF 455NG/ML WAS THE REPORTED RESULT FOR THE PATIENT. CLINICS REFERENCE RANGE FOR TRIAGE D-DIMER IS <400NG/ML. CUSTOMER STATED NO OTHER LAB TESTS WERE PERFORMED AND CUSTOMER DID NOT KNOW PATIENT DIAGNOSIS/OUTCOME, TREATMENT OR MEDICAL HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853079 ↗
• MalfunctionSep 6, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED VARIABILITY BETWEEN RESULTS PRODUCED ON THE TRIAGE D-DIMER SYSTEM. CUSTOMER STATED ON (B)(6) 2018 A PATIENT PRESENTED TO THE CLINIC WITH "PAIN IN LOWER LEFT EXTREMITY (CLOT)". PATIENT SAMPLE WAS TESTED ON TRIAGE AND PRODUCED D-DIMER RESULTS OF 202NG/ML, 163NG/ML, AND 571NG/ML. THE SPECIFIC TIME OF TESTING WAS NOT PROVIDED BUT CUSTOMER STATED TESTING WAS ALL DONE ON THE SAME DAY. CLINICS REFERENCE RANGE FOR TRIAGE D-DIMER IS <400NG/ML. CUSTOMER STATED NO OTHER LAB TESTS WERE PERFORMED AND CUSTOMER DID NOT KNOW PATIENT DIAGNOSIS/OUTCOME, TREATMENT OR MEDICAL HISTORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7853057 ↗
• InjuryOct 11, 2017High Test Results; High Test Results

  ON (B)(6) 2017, THE PATIENT ARRIVED AT THE PHYSICIAN'S OFFICE COMPLAINING OF CHEST PAIN. BOTH D-DIMER AND TNI TESTING WAS CONDUCTED ON THE PATIENT. A WHOLE-BLOOD EDTA SAMPLE WAS COLLECTED AT 4:30 PM AND THE TRIAGE D-DIMER PANEL PRODUCED AN ABNORMAL D-DIMER RESULT OF 1030 NG/ML D-DU. THE TNI RESULTS ARE NOT AVAILABLE PER CUSTOMER BUT PRODUCED A NORMAL RESULT. BASED ON THE ABNORMAL D-DIMER RESULT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR A CHEST CT. THE CHEST CT SHOWED NO EVIDENCE OF PULMONARY EMBOLISM AND NO EVIDENCE OF ACUTE CARDIO PULMONARY DISEASE. AT THE EMERGENCY ROOM, CONFIRMATORY TESTING WAS CONDUCTED USING THE HEMOSIL SYSTEM AND RESULTED IN A NORMAL D-DIMER VALUE OF 300 NG/ML D-DU. ON (B)(6) 2017, THE SAME WHOLE-BLOOD EDTA SAMPLE WAS TESTED AN ADDITIONAL TWO TIMES AT APPROXIMATELY 1:00 PM. THE TRIAGE D-DIMER PANEL PRODUCED ABNORMAL RESULTS OF 968 NG/ML D-DU AND 825 NG/ML D-DU. THE FACILITY'S NORMAL D-DIMER CUTOFF FOR BOTH THE TRIAGE AND HEMOSIL SYSTEMS WAS REPORTED TO BE 400 NG/ML D-DU.

  Patient problems: No Code Available

  MAUDE report 6942683 ↗