Triage 97021HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 30014613337935), received between Mar 24, 2020 and May 28, 2026 — classified as 42 malfunctions.

The most frequently reported specific device problem is “High Test Results” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K030286); they may or may not involve this specific model.

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.

Recalls naming this device

1. May 25, 2023Open, Classified

   Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternate method is recommended, if unavailable, use recommendations to mitigate potential patient impact, which could be missed/delayed myocardial infarction diagnosis.

   Z-1974-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026High Test Results

  EVENT OCCURRED IN THE UNITED STATES. CUSTOMER ALLEGED DISCREPANT HIGH TNI ON TRIAGE VS ROCHE COBAS FOR 1 PATIENT. 33-YEAR-OLD MALE. SYMPTOMS= ALLERGIC REACTION TO EGGS, SOME SOB, SOME CHEST DISCOMFORT ATTRIBUTED TO ACID REFLUX, VOMITING. EKG- NON-ISCHEMIC. CHEST X-RAY WAS NEGATIVE FOR ANY ACUTE FINDINGS. TRIAGE TNI: 0.13 NG/ML; CUTOFF: 0.05NG/ML. SAMPLE COLLECTED @2:55, TESTED @ 3:25. ROCHE COBAS HS-TNI: 0.13, 0.13 NG/L; CUTOFF: 22NG/L. COLLECTED @6:28, TESTED AT @7:04. REDRAW COLLECTED @7:33, TESTED AT @7:53. TRIAGE SAMPLE WAS K2 EDTA WB COLLECTED AT 2:55. ROCHE COBAS SAMPLE WAS LI HEPARIN COLECTED AT 6:28, RESULTED AT 7:04. 2ND DRAW COLLECTED AT 7:33 AND RESULTED AT 7:53.

  Patient problems: Chest Pain; Vomiting

  MAUDE report 25325397 ↗
• MalfunctionMay 7, 2026Low Readings

  EVENT OCCURRED IN THE UNITED STATES. CUSTOMER REPORTED CORRELATIONS BETWEEN TRIAGE AND VITROS ON 2 PATIENTS. CUSTOMER INSTRUCTED STAFF TO SPIN THE PATIENT'S EDTA CBC TUBES TO PLASMA AND FREEZE WHEN THEY GOT AN ELEVATED LIHEP SAMPLE FROM SAME PATIENT ON THE VITROS. PATIENT 1: (B)(6) 2026: THAWED PLASMA SAMPLE WAS TESTED ON THE TRIAGE TNI PANEL: <0.05NG/ML. THE FRESH VITROS SAMPLE TESTED 0.12 NG/ML PATIENT'S SYMPTOMS, TREATMENTS, DISCHARGE DIAGNOSES: UNKNOWN. PATIENT 2: VITROS 0.27 AND TRIAGE TNI <0.05 NG/ML NO ADDITIONAL DETAILS WERE AVAILABLE. CUT-OFFS: TRIAGE UNSURE; VITROS 0.12 NO DEATH OR SERIOUS INJURY REPORTED. TRIAGE IS BEING USED AS A BACK-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25118847 ↗
• MalfunctionApr 24, 2026Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER STATED THEY ARE CURRENTLY PERFORMING TROPONIN CORRELATIONS USING THE ISTAT, VITROS, AND THE LOANER TRIAGE METERPRO. THEY STATED THAT CORRELATION TESTING FAILING, WITH 6 OUT OF THE 8 RESULTS FAILING (4 VALUES UPON RE-EVALUATION). NO FURTHER PATIENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990414 ↗
• MalfunctionApr 23, 2026High Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TRIAGE TNI RESULTS AS WELL AS CONFLICTING RESULTS COMPARED TO ROCHE COBAS HS-TNT OVER 1 PATIENT. LOT# T16153, SN: (B)(6). THE QUIDEL TNI RESULTS WOULD BE POSITIVE AND IN THE CRITICAL RANGE. THIS WOULD TRIGGER THE PATIENT TO BE TRANSFERRED TO ONE OF OUR LARGER HOSPITALS. THE REFERRING HOSPITAL WOULD ORDER AT TROPONIN T HIGHLY SENSITIVE, WHICH IS WHAT IS RUN IN OUR CORE LABS. THE TNT HS IS RAN ON THE ROCHE COBAS WOULD COME BACK WITH A RESULT OF <6 NG/L OR IN NORMAL RANGE FOR THAT SEX. PATIENT INFORMATION: MALE. NO EKG CHANGES THAT WOULD CONCERN THE PHYSICIAN, BUT HE RAN A TROPONIN AS PART OF THE WORKUP DUE TO SPECIFIC SYMPTOMS. THE PATIENT IS ALSO NOT ON ANY BIOLOGICAL DRUGS AND HAS NOT BEEN DIAGNOSED WITH ANY AUTOIMMUNE DISEASES. SX: LOW BACK PAIN RADIATING UP. DX: PATIENT WAS TRANSPORTED TO A LARGER HOSPITAL FOR RIGHT SCIATICA PAIN AND INTERNAL HERNIA. CUSTOMER STATED THE PATIENT IN QUESTION WAS NOT TAKING ANY MEDICATIONS. THE PATIENT WAS NOT TREATED BASED ON TRIAGE TNI RESULT. SAMPLE INFORMATION: TRIAGE: WB-EDTA COLLECTED VIA VENIPUNCTURE COLLECTED AROUND 12:00 PM ON (B)(6) 2026, RE-DRAW AT 13:00. ROCHE: AROUND 12:45 PM, SAMPLE WAS COLLECTED IN LI

  Patient problems: Back pain; Hernia; Pain

  MAUDE report 24975156 ↗
• MalfunctionApr 23, 2026High Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TRIAGE TNI RESULTS AS WELL AS CONFLICTING RESULTS COMPARED TO ROCHE COBAS HS-TNT OVER 1 PATIENT. LOT# T16195, SN: (B)(6). PATIENT INFORMATION: MALE. NO EKG CHANGES THAT WOULD CONCERN THE PHYSICIAN, BUT HE RAN A TROPONIN AS PART OF THE WORKUP DUE TO SPECIFIC SYMPTOMS. THE PATIENT IS ALSO NOT ON ANY BIOLOGICAL DRUGS AND HAS NOT BEEN DIAGNOSED WITH ANY AUTOIMMUNE DISEASES. SX: LOW BACK PAIN RADIATING UP. DX: PATIENT WAS TRANSPORTED TO A LARGER HOSPITAL FOR RIGHT SCIATICA PAIN AND INTERNAL HERNIA. CUSTOMER STATED THE PATIENT IN QUESTION WAS NOT TAKING ANY MEDICATIONS. THE PATIENT WAS NOT TREATED BASED ON TRIAGE TNI RESULT. SAMPLE INFORMATION: TRIAGE: WB-EDTA COLLECTED VIA VENIPUNCTURE COLLECTED AROUND 12:00 PM ON (B)(6) 2026, RE-DRAW AT 13:00. ROCHE: AROUND 12:45 PM, SAMPLE WAS COLLECTED IN LI HEPARIN TUBE, SPAN DOWN, AND HEPARIN-PLASMA WAS SENT TO A NEARBY HOSPITAL FOR TESTING ON ROCHE HS-TNT. AT THIS POINT, IN ADDITION TO TRIAGE TNI TO ROCHE HS-TNT DISCREPANCY, CUSTOMER WAS SEEING LOT-TO-LOT DISCREPANCY AS WELL AS ORIGINAL VS REDRAW DISCREPANCY.

  Patient problems: Back pain; Hernia; Pain

  MAUDE report 24975155 ↗
• MalfunctionApr 23, 2026High Test Results

  CUSTOMER REPORTED DISCREPANT TRIAGE TNI RESULTS COMPARED TO ROCHE COBAS HS-TNT OVER 1 PATIENT LOT#: T16153, SN: (B)(6). PATIENT INFORMATION: A 40 Y/O MALE PATIENT CAME TO THE (B)(6) ON (B)(6) 2026. SX: INTERMITTENT HEADACHE LASTING FOR ABOUT A WEEK. DX: HYPERTENSION URGENCY FROM MAIN HOSPITAL. SAMPLE INFORMATION: TRIAGE WB-EDTA USED AS THE SPECIMEN, COLLECTED VIA VENIPUNCTURE. ROCHE REDRAWN BLOOD (RUN 1: 15:10, RUN 2: 19:02, 20:25); LI HEPARIN PLASMA COLLECTED VIA VENIPUNCTURE. THE PATIENT WAS NOT TREATED BASED ON TRIAGE TNI RESULT. NO REPEAT TEST ON TRIAGE TNT WAS PERFORMED. PATIENT RX: HYDROCHLOROTHIAZIDE 12.5 MG, LOSARTAN 100 MG, METOPROLOL TARTRATE 25 MG, POLYETHYLENE GLYCOL 17 GRAM POSDER.

  Patient problems: Headache; High Blood Pressure/ Hypertension

  MAUDE report 24975154 ↗
• MalfunctionApr 10, 2026High Test Results

  EVENT OCCURRED IN THE UNITED STATES OF AMERICA. CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS WITH MULTIPLE PATIENTS USING TRIAGE CARDIAC LOT T16279RN. PATIENT INFORMATION: PATIENT 1: (B)(6) 26 F 46 Y/O. SX: SMOKER, TACHYCARDIC AND MILDLY TACHYPNEIC WITH DIFFUSE WHEEZING, DX: BRONCHITIS; TREATMENT: TREATMENT FOR BRONCHITIS BASED ON QUEST. MEDICAL INTERVENTIONS/PROCEDURES: EKGS HEART SCORE. NO DELAY IN TREATMENT.

  Patient problems: Bronchitis; Tachycardia; Wheezing

  MAUDE report 24842502 ↗
• MalfunctionApr 10, 2026High Test Results

  EVENT OCCURRED IN THE UNITED STATES OF AMERICA. CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS WITH MULTIPLE PATIENTS USING TRIAGE CARDIAC LOT T16279RN. PATIENT INFORMATION: PATIENT 5: (B)(6) 2026 SX: EPIGASTRIC PAIN, DX: POTENTIAL ULCERATIVE COLITIS, TREATMENT: CONTINUED MEDS AND FOLLOW UP WITH GI. MEDICAL INTERVENTIONS/PROCEDURES: EKGS HEART SCORE NO DELAY IN TREATMENT.

  Patient problems: Abdominal Pain; Colitis

  MAUDE report 24842451 ↗
• MalfunctionApr 10, 2026High Test Results

  EVENT OCCURRED IN THE UNITED STATES OF AMERICA. CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS WITH MULTIPLE PATIENTS USING TRIAGE CARDIAC LOT T16279RN. PATIENT INFORMATION: PATIENT 4: (B)(6) 2026 M 53 Y/O SX: PMHX OF HTN AND LEFT VENTRICULAR HYPERTROPHY INITIALLY PRESENTS FOR TROUBLE SLEEPING OVER THE PAST WEEK. HE WAS SENT BY HIS THERAPIST TO POSSIBLY GET PRESCRIBED MEDICINE TO HELP HIM SLEEP. HE'S HAD ASSOCIATED CHEST TIGHTNESS AND SHORTNESS BREATH X3-4 DAYS; DISCHARGE DIAGNOSIS: ANXIETY; TREATMENT BASED ON HEART SCORE/TROPONIN RESULTS. MEDICAL INTERVENTIONS/PROCEDURES: EKGS HEART SCORE NO DELAY IN TREATMENT.

  Patient problems: Anxiety; Myocardial Hypertrophy

  MAUDE report 24842448 ↗
• MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  EVENT OCCURRED IN THE UNITED STATES OF AMERICA. CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS WITH MULTIPLE PATIENTS USING TRIAGE CARDIAC LOT T16279RN. PATIENT INFORMATION: (B)(6) 2026. SX/DX: HIGH BLOOD PRESSURE AND CHEST SENSATION, TREATMENT: SENT HOME. MEDICAL INTERVENTIONS/PROCEDURES: EKGS HEART SCORE. NO DELAY IN TREATMENT.

  Patient problems: Chest Pain; High Blood Pressure/ Hypertension

  MAUDE report 24838162 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  EVENT OCCURRED IN THE UNITED STATES OF AMERICA. TRIAGE: (B)(4). LOT: T16083RN, EXP 05-17-2026 FOR ALL OUR TESTING. USED FROZEN EDTA PLASMA ON BOTH VITROS AND TRIAGE AFTER THAWING AND CENTRIFUGING. SENT BY ST LUKES, SO NOT KNOWN HOW COLLECTED AND IF THEY WERE SPUN DOWN BEFORE THE SAMPLE WAS 4 HOURS OLD. EDTA-PLASMA FOR BOTH TRIAGE AND VITROS (FROZEN AND THAWED AT THE SAME TIME). OBSERVED PROCEDURE TO BE PER PI. CUSTOMER HAS LOT CONFIDENCE IN TRIAGE METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750009 ↗
• MalfunctionMar 31, 2026Incorrect, Inadequate or Imprecise Result or Readings

  EVENT OCCURRED IN THE UNITED STATES OF AMERICA. CUSTOMER IS VALIDATING A NEW TRIAGE FOR TROPONIN AND USING HIS ABBOTT ARCHITECT FOR METHOD COMPARISON. THEY ARE CLAIMING CORRELATION ISSUES WITH TNI ON TRIAGE CARDIAC VS ABBOTT WITH 7 PATIENT SAMPLES. PATIENT SYMPTOMS, TREATMENTS, DISCHARGE DIAGNOSES: UNKNOWN. PATIENT MEDICATIONS: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750008 ↗
• MalfunctionFeb 24, 2026Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 4 PATIENTS. THIS IS REPORT 2 OF 4. PATIENT 2: PATIENT SYMPTOMS: UNKNOWN. PATIENT DIAGNOSIS: UNKNOWN. TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435369 ↗
• MalfunctionFeb 24, 2026Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 4 PATIENTS. THIS IS REPORT 3 OF 4. PATIENT 3: PATIENT SYMPTOMS: UNKNOWN. PATIENT DIAGNOSIS: UNKNOWN. TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435365 ↗
• MalfunctionFeb 24, 2026Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 2 PATIENTS. THIS IS REPORT 1 OF 2. PATIENT 1: PATIENT SYMPTOMS: UNKNOWN. PATIENT DIAGNOSIS: UNKNOWN. TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435354 ↗
• MalfunctionFeb 24, 2026Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 4 PATIENTS. THIS IS REPORT 1 OF 4. PATIENT 1: PATIENT SYMPTOMS: UNKNOWN. PATIENT DIAGNOSIS: UNKNOWN. TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435353 ↗
• MalfunctionFeb 24, 2026Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 2 PATIENTS. THIS IS REPORT 2 OF 2. PATIENT 2: PATIENT SYMPTOMS: UNKNOWN. PATIENT DIAGNOSIS: UNKNOWN. TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435351 ↗
• MalfunctionFeb 24, 2026Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 4 PATIENTS. THIS IS REPORT 4 OF 4. PATIENT 4: PATIENT SYMPTOMS: UNKNOWN. PATIENT DIAGNOSIS: UNKNOWN. TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435313 ↗
• MalfunctionFeb 13, 2026High Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS ON TRIAGE FOR 1 PATIENT. SYMPTOMS: HAD A FALL THAT MORNING, LIGHT HEADEDNESS. DIAGNOSIS: LIGHT HEADEDNESS. TREATMENT: UNKNOWN, BASED ON NEGATIVE RESULT.

  Patient problems: Dizziness

  MAUDE report 24338282 ↗
• MalfunctionJan 14, 2026Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS ON TRIAGE VS. VITROS. PATIENT SYMPTOMS: SOB, SWELLING OF EXTREMITIES. TREATMENT: LEFT AGAINST MEDICAL ADVICE. PATIENT WAS NOT TREATED BASED ON TRIAGE. DIAGNOSIS: SWELLING, RETAINING FLUID DUE TO SEVERE CHF.

  Patient problems: Heart Failure/Congestive Heart Failure; Swelling/ Edema

  MAUDE report 24074996 ↗
• MalfunctionDec 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED POOR CORRELATION BETWEEN TRIAGE AND ARCHITECT FOR 8 PATIENTS. NO PATIENT SYMPTOMS, TREATMENTS OR DIAGNOSES WERE AVAILABLE. TREATMENT WAS NOT BASED ON TRIAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23834711 ↗
• MalfunctionDec 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED POOR CORRELATION BETWEEN TRIAGE AND VITROS FOR 3 OUT OF 13 TNI RESULTS. NO PATIENT SYMPTOMS, TREATMENTS OR DIAGNOSES WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23774360 ↗
• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 4 PATIENTS. THIS IS REPORT 2 OF 4. PATIENT 2: PATIENT SYMPTOMS: SOB, CHEST PAIN, PATIENT DIAGNOSIS: NOT PROVIDED, TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: Chest Pain

  MAUDE report 23732478 ↗
• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 4 PATIENTS. THIS IS REPORT 1 OF 4. PATIENT 1: PATIENT SYMPTOMS: SOB, CHEST PAIN, PATIENT DIAGNOSIS: NOT PROVIDED, TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: Chest Pain

  MAUDE report 23732477 ↗
• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS ON TRIAGE CARDIAC VS. VITROS FOR 4 PATIENTS. THIS IS REPORT 4 OF 4. PATIENT 4: PATIENT SYMPTOMS: SOB, CHEST PAIN, PATIENT DIAGNOSIS: NOT PROVIDED, TREATMENT: UNKNOWN, NOT BASED ON TRIAGE.

  Patient problems: Chest Pain

  MAUDE report 23732476 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030286. One submission often covers many models, so check the product and lot details in each record.

• Z-1929-2012 · May 22, 2012 · Terminated
  Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma
• Z-1391-2009 · Apr 27, 2009 · Terminated
  Triage Cardiac Panel, Biosite Catalog Number 97000HS, 25 individually pouched devices in a labeled kit box. Fluorescence immunoassay kit to be used with the Triage Meter for the