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CAPI 3 IMMUNOTYPING 2600Recalls & reported problems

Sebia · Device designed for the qualitative detection and the characterization of monoclonal proteins by capillary electrophoresis · Class 1

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 03607360026007), received between Sep 16, 2021 and Sep 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Misassembled” (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

  • Component Misassembled1

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 16, 2021Component Misassembled; Component Misassembled

    18 AUGUST 2021: THE CUSTOMER OBSERVED THAT ONE KIT OF THE CAPI 3 IMMUNOTYPING ANTISERA CARTRIDGE OUT OF THE 50 KITS RECEIVED, LOT 11021/01, PRESENTED WITH DISCORDANT RESULTS. VISUAL INSPECTION IDENTIFIED THAT TWO OF THE ANTISERA ANTI-IGA AND ANTI-IGM WERE REVERSED IN THE POSITIONS WITHIN THE SEALED CARTRIDGE. NO DISCREPANT PATIENT LABORATORY REPORTS WERE RELEASED. THERE WERE NO REPORTS OF IMPACT TO PATIENT MANAGEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12482986 ↗

Other Multi-Analyte Controls, All Kinds (Assayed) 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.