Alere Triage® 97021HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00899722002788), received between Sep 20, 2017 and Mar 6, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2019High Test Results; High Test Results

  CUSTOMER REPORTED THE FOLLOWING OCCURRING FOR ONE PATIENT. ON (B)(6) 2019 A MALE PATIENT PRESENTED TO THE ED WITH CONGESTION. AT 9:47 THE PATIENT WAS TESTED ON TRIAGE AND YIELDED A TNI OF 7.26. THE DOCTOR QUESTIONED THE RESULT BECAUSE IT WAS NOT CONSISTENT WITH PATIENT PRESENTATION. NEW SAMPLES WERE DRAWN FROM THE PATIENT AT 12:44 AND 16:37; BOTH DRAWS RESULTED IN TRIAGE TNI <0.05. CUSTOMER REPEATED THE 9:47 SAMPLE DRAW AT 18:32 AND RECEIVED A RESULT OF <0.05 TNI ON TRIAGE. CUSTOMER STATED THAT THE PATIENT WAS TREATED BASED ON SITE'S PROTOCOL FOR ELEVATED TNI WHEN THE 7.26 TRIAGE TNI RESULT WAS RECEIVED. THIS INCLUDED A SECOND EKG, A CHEST X-RAY, LABS OF CBC, CMP, CK, PT, AND PTT. ALL TESTS WERE NORMAL EXCEPT FOR ELEVATED GLU, AST AND ALT AND DECREASED CO2. THE EKG RESULT WAS STATED AS SINUS TACHYCARDIA. CUSTOMER LISTED HEPARIN AND PLAVIX AS THE MEDICATIONS PROVIDED TO THE PATIENT; IT IS UNCLEAR WHEN THESE MEDICATIONS WERE ADMINISTERED TO THE PATIENT. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA. THE CUSTOMER STATED THE ELEVATED TRIAGE TNI RESULT INCREASED THE PATIENTS' LENGTH OF STAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8396911 ↗
• MalfunctionJun 19, 2018Low Test Results; Low Test Results

  CUSTOMER REPORTED THAT A DISCORDANT TROPONINI (TNI) RESULT WAS OBTAINED WITH A PATIENT SAMPLE ON THE TRIAGE SYSTEM. PATIENT PRESENTED TO THE ER WITH CHEST PAIN. PATIENT SAMPLE TESTED ON TRIAGE YIELDED <0.05 FOR TNI AND THE LAB RESULTED A FEW MINUTES LATER WITH 0.11NG/ML. LAB RESULT WAS ON THE BECKMAN ANALYZER, CUT-OFF 0.04NG/ML. TRIAGE CUT-OFF IS 0.05NG/ML. PATIENT'S EKG WAS ABNORMAL, WITH LATERAL ST/T WAVE, INDICATING ISCHEMIA. CUSTOMERS LAB MED DIRECTOR REVIEWED THE CHART FOR THE PATIENT, STATED THE EVENT WAS COMPLICATED BECAUSE THE PATIENT WAS IN AN ACCIDENT AND THE TROPONIN ELEVATION COULD BE HEART CONTUSION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7617508 ↗
• MalfunctionSep 20, 2017Low Test Results; Low Test Results

  THE CUSTOMER WAS PERFORMING A CORRELATION STUDY BETWEEN THE TRIAGE SYSTEM AND THE DIMENSIONS EXL ANALYZER. THE FOLLOWING EVENTS WERE REPORTED OCCURRING ON ONE PATIENT: BOTH AN EDTA PLASMA AND A HEPARIN PLASMA SAMPLE WAS COLLECTED FROM THE PATIENT. THE PLASMA SAMPLES WERE COLLECTED AND STORED FROZEN OVER THE WEEKEND. ON (B)(6) 2017, THE EDTA PLASMA SAMPLE WAS TESTED USING THE TRIAGE TNI PANEL AND PRODUCED A NORMAL TNI RESULT OF 0.19 NG/ML. THE HEPARIN PLASMA SAMPLE WAS TESTED ON THE DIMENSIONS EXL ANALYZER AND PRODUCED AN ABNORMAL TNI RESULT OF 0.63 NG/ML. THERE WAS NO TREATMENT OR INTERVENTION PROVIDED BASED ON THE TRIAGE TNI RESULT. THE FACILITY'S NORMAL TRIAGE TNI CUTOFF WAS REPORTED TO BE 0.40NG/ML THE FACILITY'S NORMAL DIMENSIONS EXL ANALYZER TNI CUTOFF WAS REPORTED TO BE 0.56NG/ML.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6881606 ↗