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ARCHITECT 6L27-01Recalls & reported problems

Abbott GmbH · ARCHITECT HAVAB-G 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 00380740011161), received between Nov 26, 2019 and Nov 26, 2019 — 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 (K113704); 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

Device problems

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionNov 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    ABBOTT LABORATORIES HAS IDENTIFIED AN ISSUE DURING STABILITY TESTING WITH THE ARCHITECT HAVAB-G CALIBRATOR KIT, LIST NUMBER 06L27-01; LOT 08219BE00, WHERE THIS SPECIFIC LOT HAS THE POTENTIAL TO BE IMPACTED BY AN INCREASE IN THE RELATIVE LIGHT UNITS (RLUS) OF UP TO 95%. WITH THE INCREASE IN THE CALIBRATOR RLU VALUES, THERE IS THE POTENTIAL FOR CONTROL VALUES AND PATIENT RESULTS GENERATED WITH THE IMPACTED CALIBRATOR LOT TO BE DECREASED, WHICH MAY CHANGE INTERPRETATIONS OF RESULTS FROM REACTIVE TO FALSELY NON-REACTIVE. THERE HAS BEEN NO REPORTED IMPACT TO PATIENT MANAGEMENT AS A RESULT OF THIS ISSUE.

    Patient problems: No Patient Involvement

    MAUDE report 9376289 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113704. One submission often covers many models, so check the product and lot details in each record.

  • Z-1728-2020 · Mar 9, 2020 · Terminated
    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
  • Z-0574-2020 · Nov 7, 2019 · Terminated
    ARCHITECT HAVAB-G Calibrator, REF 6L27-01

Other CALIBRATOR, PRIMARY devices

All CALIBRATOR, PRIMARY devices →

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