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ARCHITECT 1L75-55Recalls & reported problems

Abbott Laboratories · ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit · 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 00380740001322), received between Jun 27, 2022 and Jun 27, 2022 — 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 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.

  • MalfunctionJun 27, 2022Low Test Results; Low Test Results

    THE CUSTOMER OBSERVED FALSELY DECREASED ARCHITECT CYCLOSPORINE RESULT WHICH QUESTIONED BY PHYSICIAN ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL=63 NG/ML /REPEATED=69 NG/ML /REDRAWN AND REPEATED ON SAME PATIENT=170 NG/ML AND 180 NG/ML /INITIAL SPECIMEN REPEATED=69 NG/ML THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14831877 ↗

Other CALIBRATORS, DRUG SPECIFIC devices

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