Triage 97022HSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30014613337942), received between May 15, 2025 and May 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025High Test Results; High Test Results

  CUSTOMER ALLEGING DISCREPANT HIGH TNI WITH TRIAGE CARDIAC LOT T15228RN VS ER METHOD (HSTNI) FOR 1 PATIENT. SYMPTOMS: UNKNOWN DIAGNOSIS: UNKNOWN TRIAGE DEVICE THAWED PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031503 ↗

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