ADVIA Centaur® CsA 10335448Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414524450), received between Apr 17, 2018 and Apr 17, 2018 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (K071455); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HIGH ADVIA CENTAUR XP CYCLOSPORINE (CSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE DURING A METHOD COMPARISON. THE CYCLOSPORINE RESULTS WERE HIGHER THAN THE LC-MS/MS METHODS. THE PATIENT SAMPLE WAS TESTED ON THE LC-MS/MS AT TWO LABORATORIES. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY ONE PHYSICIAN. CORRECTED RESULTS WERE REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYCLOSPORINE (CSA) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071455. One submission often covers many models, so check the product and lot details in each record.

• Z-1687-2018 · Jan 2, 2018 · Terminated
  ADVIA Centaur Cyclosporine