ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q 10310296Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00630414202921), received between Jan 29, 2018 and Jan 29, 2018 — classified as 2 malfunctions.

1 other recall cover devices cleared under the same FDA submission (P950021); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT HIGH ADVIA CENTAUR XP PSA RESULTS WERE OBTAINED FOR SAMPLES FROM FIVE PATIENTS WHEN CHANGING CALIBRATOR LOT NUMBERS. THE CUSTOMER SWTICHED FROM CALIBRATOR LOT CQ72 FROM LOT CQ74 USING THE SAME REAGENT LOT 282. THE RESULTS WERE HIGHER WITH LOT CQ74. THE CUSTOMER ALSO HAD HIGH RECOVERY WITH THE QUALITY CONTROL. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7224242 ↗
• MalfunctionJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT HIGH ADVIA CENTAUR XP PSA RESULTS WERE OBTAINED FOR SAMPLES FROM TWO PATIENTS WHEN CHANGING CALIBRATOR LOT NUMBERS. THE CUSTOMER SWTICHED FROM CALIBRATOR LOT CQ72 FROM LOT CQ74 USING THE SAME REAGENT LOT 282. THE RESULTS WERE HIGHER WITH LOT CQ74. THE CUSTOMER ALSO HAD HIGH RECOVERY WITH THE QUALITY CONTROL. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PSA RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7224238 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P950021. One submission often covers many models, so check the product and lot details in each record.

• Z-2742-2016 · Aug 9, 2016 · Terminated
  ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)