Triage 97000HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30014613337911), received between Feb 28, 2020 and Sep 16, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (4 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793170 ↗
• MalfunctionSep 16, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793167 ↗
• MalfunctionSep 16, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793163 ↗
• MalfunctionFeb 4, 2026Low Readings

  CUSTOMER REPORTED DISCREPANT TNI RESULTS DURING CORRELATION OF TRIAGE CARDIAC WITH VITROS ON 5 SAMPLES. NO LOT NUMBER, PATIENT SYMPTOMS, OR DIAGNOSIS PROVIDED. NO PATIENT DEATH OR AE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263520 ↗
• MalfunctionJan 23, 2026High Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS ON TRIAGE CARDIAC VS VITROS FOR 1 PATIENT. PATIENT 1: SYMPTOMS: NONE REPORTED, PATIENT JUST HAD A BABY. DIAGNOSIS: UNKNOWN. TREATMENT: N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24172237 ↗
• MalfunctionDec 5, 2025High Test Results; High Test Results

  CUSTOMER REPORTED DISCREPANT HIGH TNI RESULTS ON TRIAGE CARDIAC VS UNKNOWN LAB METHOD FOR 1 PATIENT. PATIENT SYMPTOMS: CHEST PAIN, CHEST TIGHTNESS FOR 4 DAYS DIAGNOSIS: CHONDROCOSTAL JUNCTION SYNDROM. TREATMENT: PROTONIX, GI COCKTAIL OF MYLANTA, BENADRYL AND LIDOCAINE, TORADOL FOR PAIN. TREATMENT WAS NOT BASED ON TRIAGE RESULTS. PATIENT DISCHARGED AFTER NEGATIVE CONFIRMATORY TESTING FROM EXTERNAL LAB.

  Patient problems: Chest Pain

  MAUDE report 23732474 ↗
• MalfunctionOct 16, 2025Low Test Results; Low Test Results

  CUSTOMER REPORTED DISCREPANT LOW TNI RESULTS FOR ONE PATIENT ON TRIAGE VS. ATELLICA HS-TNI METHOD. PATIENT SYMPTOMS: MILD CHEST DISCOMFORT, ACHING SENSATION RADIATING TO BOTH ARMS PATIENT DIAGNOSIS AND TREATMENT: PATIENT WAS INITIALLY DISCHARGED, THEN CALLED BACK TO THE ER. HEPARIN (100 UNITS/ML), IV INFUSION (1000 UNITS/HR) (NITROGLYCERIN 0.4 MG, HEPARIN INJECTION 5000 UNITS). PATIENT WAS TRANSFERRED TO THE HOSPITAL.

  Patient problems: Chest Pain

  MAUDE report 23317929 ↗
• MalfunctionNov 6, 2024High Test Results; High Test Results

  CUSTOMER REPORTED TRIAGE WAS POSITIVE AND LABORATORY METHOD WAS NEGATIVE FOR ONE PATIENT. CUSTOMER FOUND THAT SEVERAL SAMPLES COLLECTED THAT DAY WERE NOT FULLY FILLED IN THE 4.0 TUBES. UNKNOWN WHETHER THE SAMPLE FOR THIS PATIENT WAS AFFECTED. NO PATIENT DATA AVAILABLE, PATIENT HAD GENERAL CHEST PAINS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Chest Pain

  MAUDE report 20616203 ↗
• MalfunctionFeb 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED THE FOLLOWING OCCURRING FOR ONE PATIENT. ON (B)(6) 2020, A MALE PATIENT PRESENTED WITH LIGHT HEADEDNESS, NAUSEA AND RINGING EARS. PATIENT WAS GIVEN ZOFRAN AND FLUIDS. PATIENT WAS TESTED ON THE TRIAGE PLATFORM FOUR TIMES. 17:16: TRIAGE METER SERIAL NUMBER (B)(6) : CKMB: 3.5; MYO: 147; TNI: 0.17. 17:21: TRIAGE METER SERIAL NUMBER (B)(6) : CKMB: 4.1; MYO: 144; TNI: <0.05. 17:25: TRIAGE METER SERIAL NUMBER (B)(6) : CKMB: 3.7; MYO: 141; TNI: <0.05. 17:34: TRIAGE METER SERIAL NUMBER (B)(6) : CKMB: 3.8; MYO: 142; TNI: <0.05 . FACILITY TRIAGE CUT-OFF FOR TNI: 0.05. PATIENT WAS DISCHARGED ON (B)(6) 2020 WITH NO MEDS. CUSTOMER PROVIDED AN UPDATE ON 3/2/2020. PATIENT "FINAL DX OF MYOCARDITIS".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9772076 ↗
• MalfunctionFeb 28, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED THE FOLLOWING OCCURRING FOR ONE PATIENT. ON (B)(6) 2020, A FEMALE PATIENT PRESENTED TO THE CUSTOMERS FACILITY WITH PAIN IN CHEST. PATIENT WAS GIVEN NITRO PATCH, ASPIRIN AND ATIVAN. PATIENT WAS TESTED ON THE TRIAGE PLATFORM THREE TIMES. 16:15: METER SERIAL NUMBER (B)(6): CKMB: <1.0; MYO: 37.8; TNI: 0.22. 16:21: METER SERIAL NUMBER (B)(6): CKMB: <1.0; MYO: 48.0; TNI: <0.05. 16:40: METER SERIAL NUMBER (B)(6): CKMB: <1.0; MYO: 48.7; TNI: <0.05. FACILITY TRIAGE CUT-OFF FOR TNI: 0.05 CUSTOMER PROVIDED AN UPDATE ON 3/2/2020. PATIENT "FINAL DX OF MYOCARDITIS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771726 ↗

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