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ARCHITECT 7K78-01Recalls & reported problems

Abbott Ireland · ARCHITECT Total Beta hCG Calibrators · 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 00380740014933), received between Sep 13, 2018 and Sep 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low 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

  • Low Test Results1

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.

  • MalfunctionSep 13, 2018Low Test Results; Low Test Results

    THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT B-HCG RESULTS. THE CUSTOMER PROVIDED DATA FOR ONE PREGNANT PATIENT, AS FOLLOWS (MIU/ML): (B)(6). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7875699 ↗

Other SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN devices

All SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN devices →

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