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ARCHITECT 3L82-41Recalls & reported problems

Abbott Laboratories · Glucose · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740006013), received between Jul 24, 2017 and Dec 1, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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

  • High Test Results1
  • Incorrect Or Inadequate Test Results1

Patient problems

  • No Known Impact Or Consequence To Patient2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 1, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

    UPDATE JANUARY 10, 2018. THE INITIAL RESULT WAS ASSOCIATED WITH SID (B)(6) AND THE REPEAT RESULT WAS ASSOCIATED WITH SID (B)(6).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7076646 ↗
  • MalfunctionJul 24, 2017High Test Results; High Test Results

    THE CUSTOMER OBSERVED A FALSELY ELEVATED CLINICAL CHEMISTRY GLUCOSE RESULT WHILE USING THE ARCHITECT C8000 ANALYZER. THE CUSTOMER PROVIDED THE FOLLOWING DATA: (B)(6). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6735647 ↗

Other HEXOKINASE, GLUCOSE devices

All HEXOKINASE, GLUCOSE devices →

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