Alere Triage® 97000HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00893038002197), received between May 3, 2017 and Oct 18, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2019Low Test Results; Low Test Results

  PATIENT, A (B)(6) BOY, PRESENTED TO THE ER WITH CHEST PAIN THAT WOKE HIM UP TWICE IN THE NIGHT AND A HEADACHE FROM HITTING HIS HEAD WHEN ROUGH HOUSING WITH HIS BROTHER. CAME TO ER, (B)(6) 2019 AT 12:25 A.M. DRAW TIMES AND TEST TIMES UNAVAILABLE FOR THE SIEMENS DIMENSION, BUT TESTING WOULD HAVE BEEN PERFORMED 15 TO 30 MINUTES PRIOR TO THE TRIAGE SINCE TRIAGE IS THE BACKUP TO THE SIEMENS DIMENSION SIEMENS DIMENSION EXL TROPONIN: LITHIUM HEPARIN, PLASMA; RESULT=0.204, SST, SERUM, RESULT=0.216, LITHIUM HEPARIN, PLASMA; RESULT=0.221. TRIAGE TESTS LAVENDER TOP (EDTA) WB SAMPLE TRIAGE METER, 2 DRAWS, RESULT= <0.05 X2 AT 1:45 A.M. AND 2:22 A.M. MYO=34.2 AND 42.8; CK-MB=2.4 AND 3.1. TRIAGE METER RANGE TNI: NORMAL IS <0.05. SIEMENS DIMENSION REFERENCE RANGE: 0.000-0.050. CUSTOMER STATED NO TREATMENTS WERE WITHHELD BASED ON TRIAGE RESULTS. PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. ALTHOUGH REQUESTED, PATIENT DIAGNOSIS IS NOT AVAILABLE. TREATING DOCTOR AT CUSTOMER SITE FEELS THAT THE CHILD HAS ACUTE MYOCARDITIS. CUSTOMER STATED TRIAGE WAS PASSING CONTROLS WITHOUT ANY ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9211001 ↗
• MalfunctionFeb 27, 2019Low Test Results; Low Test Results

  CUSTOMER REPORTED DISCORDANT RESULTS FOR ONE PATIENT SAMPLE DRAWN FROM PATIENT ON (B)(6) 2019 AT 15:01. SAMPLE TESTED ON TOSOH AT 15:17 AND YIELDED TNI 0.65 AND MYO 50.9 (CKMB NOT TESTED ON TOSOH). SAMPLE THEN TESTED ON TRIAGE AT 15:45 AND YIELDED TNI <0.05NG/ML, CKMB 2.4NG/ML AND MYO 136NG/ML. SITES NORMAL RANGES ARE: TRIAGE TNI <0.05NG/ML TOSOH <0.4 CUSTOMER STATED SAMPLES WERE STORED REFRIGERATED FOR 4 DAYS AND RETESTED ON BOTH TRIAGE AND TOSOH (TESTING DATE OF (B)(6) 2019). TRIAGE TNI <0.05NG/ML, MYO 237 TOSOH TNI 1.16. CUSTOMER STATED THAT THE TRIAGE METER IS BACKUP TO THE TOSOH INSTRUMENT. CUSTOMER STATED THEY DID NOT BELIEVE THE PATIENT WAS HAVING A HEART ATTACK AS SUGGESTED BY THE TOSOH INSTRUMENT. CUSTOMER ALSO CALLED TOSOH FOR TROUBLESHOOTING. CUSTOMER COULD NOT PROVIDE ADDITIONAL PATIENT INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8376175 ↗
• MalfunctionJul 23, 2018High Readings; High Readings

  THE CUSTOMER REPORTING RECEIVING CONFLICTING TRIAGE TNI RESULTS FOR A MALE PATIENT. TRIAGE TNI RESULTS WERE AS FOLLOWS: (B)(6). CUSTOMER COULD NOT PROVIDE THE REASON FOR THE PATIENTS VISIT TO THE ED, PATIENTS' MEDICAL HISTORY, PATIENTS' MEDICATION LIST OR RESULTS FROM THE EKG. CUSTOMER STATED PATIENT WAS NOT TREATED ON TRIAGE RESULTS. PATIENTS' OUTCOME WAS NO MI AND PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712391 ↗
• MalfunctionFeb 7, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED OBSERVING A VARIANCE FOR MYOGLOBIN DURING A LOT TO LOT COMPARISON WITH TWO DIFFERENT TRIAGE CARDIAC LOT NUMBERS. PATIENT RESULTS: TRIAGE CARDIAC LOT W63243B, MYO=90.1, TRIAGE CARDIAC LOT W63316B, MYO=118. MYOGLOBIN REFERENCE RANGE: 0-106 NG/ML. PATIENT WAS NOT TREATED BASED ON THE TRIAGE RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7250241 ↗
• MalfunctionJul 7, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE FOLLOWING EVENTS OCCURRING FOR ONE PATIENT: ON (B)(6) 2017, THE PATIENT ARRIVED AT AN OUTPATIENT CENTER COMPLAINING OF CHEST PAIN AND SHORTNESS OF BREATH. THE PHYSICIAN ORDERED A TNI TEST TO BE CONDUCTED AND A SERUM SAMPLE WAS COLLECTED. THE SERUM WAS RUN ON THE BECKMAN ACCESS DXI AT 4:35PM AND YIELDED A TNI RESULT OF 6.57 NG/ML. BASED ON THIS RESULT, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. THE PRELIMINARY DIAGNOSIS FOR HOSPITALIZATION WAS ELEVATED NON-STEMI MYOCARDIAL INFARCTION. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT AT 8:46PM AND RAN ON THE BECKMAN ACCESS DXI. THE TEST PRODUCED A TNI RESULT 6.3 NG/ML. AT 9:21PM, THE SAME SAMPLE WAS ALSO TESTED ON TRIAGE METER SERIAL NUMBER (B)(4) AND PRODUCED THE FOLLOWING RESULTS: CKMB= 5.6 NG/ML, MYO= 110 NG/ML, AND TNI=<0.05 NG/ML. AT 10:44PM, THE SAME SAMPLE WAS ALSO TESTED ON AN ALTERNATIVE TRIAGE METER SERIAL NUMBER (B)(4) AND PRODUCED THE FOLLOWING RESULTS: CKMB= 4.2 NG/ML, MYO= 96.0 NG/ML, AND TNI=<0.05 NG/ML. ON (B)(6) AT 12:09AM, A SAMPLE FROM ONE OF THE PREVIOUS DRAWS WAS TESTED ON A THIRD TRIAGE METER SERIAL NUMBER (B)(4) AND PRODUCED THE FOLLOWING RESULTS: CKMB= 4.6 NG/ML, MYO= 94.8 NG/ML, A

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6695219 ↗
• MalfunctionMay 3, 2017Low Test Results; Low Test Results

  THE CUSTOMER REPORTED THE FOLLOWING EVENTS OCCURRING ON ONE PATIENT: ON (B)(6) 2017, THE PATIENT WALKED INTO THE EMERGENCY DEPARTMENT WITH A HIGH FEVER AND WAS ADMITTED. BOTH AN EDTA PLASMA SAMPLE AND A HEPARIN PLASMA SAMPLE WERE COLLECTED FROM THE PATIENT. THE EDTA PLASMA SAMPLE WAS TESTED USING THE TRIAGE CARDIAC TRIPLE MARKER PANEL AND PRODUCED A TNI RESULT OF <0.05 NG/ML. THE HEPARIN PLASMA SAMPLE WAS TESTED USING THE SIEMENS EXL AND PRODUCED A TNI RESULT OF 0.104 NG/ML. THE CUSTOMER PROVIDED THE FOLLOWING REFERENCE RANGES: <0.056 NG/ML (NEGATIVE); 0.057-0.099 NG/ML (INTERMEDIATE RISK); >0.100 NG/ML (HIGH RISK). THE CUSTOMER IS UNABLE TO PROVIDE ANY INFORMATION REGARDING THE DIAGNOSIS OF THE PATIENT. HOWEVER, NO TREATMENT OR INTERVENTION WAS ADMINISTERED OR WITHHELD BASED ON THE TRIAGE TNI RESULT. AS OF (B)(6) 2017, THE PATIENT HAD NOT BEEN DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6542033 ↗