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ARCHITECT 1P36-27Recalls & reported problems

Abbott GmbH · ARCHITECT iCarbamazepine 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 00380740081072), received between Apr 27, 2017 and Apr 27, 2017 — classified as 1 malfunction.

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

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.

  • MalfunctionApr 27, 2017High Test Results; High Test Results

    THE CUSTOMER OBSERVED FALSELY ELEVATED CARBAMAZEPINE RESULTS WHILE USING THE ARCHITECT CARBAMAZEPINE ASSAY. THERAPEUTIC RANGE 4.0 - 12.0UG/ML, >20.0UG/ML TOXIC. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (UG/ML): SID (B)(6): (B)(6) 2016: INITIAL > 15 (FLAGGED RESULT), RETESTED (1:4 DILUTION) 50.40. RETESTED USING NEW REAGENT PACK: 10.61. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6525467 ↗

Other ENZYME IMMUNOASSAY, CARBAMAZEPINE devices

All ENZYME IMMUNOASSAY, CARBAMAZEPINE devices →

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