Alere Triage® 97022HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00899722002795), received between Mar 23, 2018 and Nov 22, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2018High Test Results; High Test Results

  ON (B)(6) 2018 A PATIENT PRESENTED TO THE CUSTOMERS' FACILITY WITH SHORTNESS OF BREATH (NO OTHER SYMPTOMS NOTED). FACILITY RAN THE TRIAGE PANEL ON THE PATIENT.  TNI=0.48NG/ML, CKMB= LESS THAN 1.0NG/ML. SITE'S CRITICAL CUTOFF FOR TNI IS GREATER THAN 0.50NG/ML, HOWEVER THE RESULT OF 0.48NG/ML WAS CONSIDERED ABNORMAL.  PATIENT WAS THEN SENT TO THE ER FOR FURTHER EVALUATION. (TO CUSTOMER'S KNOWLEDGE NO FURTHER ACTION OR TREATMENT WAS TAKEN BASED OFF OF THE TRIAGE RESULT).  ER TESTED TNI ON THEIR BECKMAN SYSTEM, TNI = LESS THAN 0.03. A TOTAL OF 3 DRAWS WERE OBTAINED (4 HOURS APART) AND ALL RESULTED LESS THAN 0.03NG/ML ON BECKMAN FOR THE PATIENT. CUSTOMER STATED THE ER COMMUNICATED THEIR TNI RESULT(S) TO THEM AND SO THE FACILITY RERAN THE PATIENT SAMPLE ON THE TRIAGE PANEL WITH A NEW TEST DEVICE, SAME DRAW ( AT ROOM TEMPERATURE PAST 4 HOURS FROM COLLECTION). REPEAT TNI= LESS THAN 0.05NG/ML.   PATIENT WAS DISCHARGED ON (B)(6) 2018. NO FURTHER INFORMATION AVAILABLE ON DIAGNOSIS, IT IS UNKNOWN IF AN EKG WAS PERFORMED AT THE EMERGENCY ROOM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098926 ↗
• MalfunctionMar 23, 2018High Test Results; High Test Results

  CUSTOMER REPORTED IMPRECISION RESULTS FOR CKMB ON TRIAGE LOT NUMBER W63532RB FOR A PATIENT. ON (B)(6) 2018, PATIENT WAS TESTED AND THE FOLLOWING RESULTS WERE RECEIVED: 7:30AM: SAMPLE 1, RESULTED CKMB 5.3NG/ML; 10:30AM: SAMPLE 2, REDRAW (NEW DEVICE) RESULTED CKMB 3.0NG/ML CUSTOMERS CKMB CUT-OFF: 4.3NG/ML. PATIENT WAS ADMINISTERED HEPARIN BOLUS FOLLOWED BY A HEPARIN DRIP PRIOR TO THE 10:30AM DRAW AND RESULT. PATIENT OUTCOME: FLARE UP OF CHF WITH NO MI. PATIENT IS DOING WELL IN SKILLED BED AT THIS TIME. CUSTOMER PROVIDED ADDITIONAL INFORMATION ON 2/27/2018 OF THEIR REPEAT TESTING FOR THE TWO PATIENT DRAWS: REPEAT TESTING: SAMPLE 1 (SAME TUBE OF 7:30AM DRAW) USING PLASMA RESULTED CKMB=4.4. SAMPLE 2 (SAME TUBE OF 10:30AM DRAW) USING PLASMA RESULTED CKMB=3.2, (3) SAMPLE 2 (SAME TUBE OF 10:30AM DRAW) USING WB RESULTED CKMB=2.7. THERE IS NO INFORMATION TO SUGGEST THE TRIAGE CKMB RESULT OF 5.3NG/ML ALTERED PATIENT TREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7367239 ↗