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ARCHITECT 7D58-22Recalls & reported problems

Abbott GmbH · Amylase · 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 00380740161668), received between Sep 19, 2022 and Sep 19, 2022 — classified as 1 malfunction.

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

  • Incorrect, Inadequate or Imprecise Result or Readings1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    THE CUSTOMER IDENTIFIED AN ISSUE WITH THE ARCHITECT AMYLASE REAGENT ON THE ARCHITECT C16000. THE CUSTOMER OBTAINED MULTIPLE (SAMPLE ID (B)(6)) INACCURATE GLUCOSE RESULT THAT WERE FLAGGED <0.28 MMOL/L. WHEN THE ANALYZER WAS INSPECTED THEY FOUND AMYLASE IN THE CAROUSEL POSITION THE ANALYZER INDICATED GLUCOSE WAS IN THEREFORE INDICATING THE ANALYZER MAY HAVE READ THE AMYLASE REAGENT AS GLUCOSE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15451296 ↗

Other CATALYTIC METHODS, AMYLASE devices

All CATALYTIC METHODS, AMYLASE devices →

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