Triage 98100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30014613338000), received between Jul 29, 2021 and Jul 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K042890); 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.

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.

• MalfunctionJul 29, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER CALLED IN PRECISION ISSUE WITH THE TRIAGE D-DIMER PANEL WITH ONE PATIENT. ON (B)(6) 2021 PATIENT CAME INTO FACILITY WITH CLOTTING ISSUES. PATIENT WAS BEING TREATED FOR THE CLOTTING AND REHYDRATED BASED ON SYMPTOMS PRIOR TO PHYSICIANS RECEIVING THE INITIAL D-DIMER RESULT. INITIAL D-DIMER RESULT ON TRIAGE >5000NG/ML. AN HOUR LATER A NEW DRAW WAS COLLECTED AND D-DIMER RESULT ON TRIAGE <100NG/ML. SITE CUT-OFF FOR D-DIMER ON TRIAGE >600NG/ML. NO CONFIRMATORY TESTING PERFORMED. PATIENT FLOWN TO ALTERNATE HOSPITAL FOR CARE, NO ADDITIONAL INFORMATION ON PATIENT AVAILABLE. CUSTOMER THINKS SHE RECALLS THE FIRST SAMPLE HAVING SOME CLUMPING, POSSIBLY COLD AGGLUTINATION, OR AGGREGATION; HOWEVER, NOT SURE. AN UPDATE PROVIDED BY THE CUSTOMER, STATED THE PATIENT WAS TREATED WITH HEPARIN AND NURSE MAY HAVE DRAWN THE SAMPLE. CUSTOMER NOT SURE IF THE DRAW WAS TAKEN FROM THE ARM RECEIVING HEPARIN. CUSTOMER STATED IT MIGHT HAVE BEEN A SAMPLE DRAW ERROR, BUT NOT SURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250335 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042890. One submission often covers many models, so check the product and lot details in each record.

• Z-1727-2014 · May 2, 2014 · Terminated
  Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determinat
• Z-1932-2012 · May 22, 2012 · Terminated
  Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including p