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ARCHITECT 5P04-01Recalls & reported problems

Abbott Laboratories · TDM Multiconstituent Calibrator · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740101220), received between Oct 29, 2018 and Oct 29, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (1 report).

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

Device problems

  • Device Ingredient or Reagent Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 29, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

    IVD TEST FOR VANCOMYCIN REVEALED UNUSUALLY LOW RESULT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8017680 ↗

Other CALIBRATOR, MULTI-ANALYTE MIXTURE devices

All CALIBRATOR, MULTI-ANALYTE MIXTURE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.