ADVIA Centaur® PRL 10309976Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414177274), received between Dec 19, 2017 and Nov 3, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K904714); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER TESTED PATIENT SAMPLES ACROSS MULTIPLE DAYS USING ADVIA CENTAUR XP PROLACTIN (PRL) LOT 203 AND OBSERVED IMPRECISION IN THE RESULTS. INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. IT IS NOT KNOWN WHICH RESULTS ARE CORRECT. IT IS NOT KNOWN WHICH RESULTS WERE ACCEPTED BY THE PHYSICIAN(S) AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROLACTIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15719657 ↗
• MalfunctionNov 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER TESTED PATIENT SAMPLES ACROSS MULTIPLE DAYS USING ADVIA CENTAUR XP PROLACTIN (PRL) LOT 203 AND OBSERVED IMPRECISION IN THE RESULTS. INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. IT IS NOT KNOWN WHICH RESULTS ARE CORRECT. IT IS NOT KNOWN WHICH RESULTS WERE ACCEPTED BY THE PHYSICIAN(S) AS CORRECT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROLACTIN RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15719529 ↗
• MalfunctionDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT LOW ADVIA CENTAUR XP PROLACTIN (PRL) RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE RESULTS WERE DISCORDANT WITH THE HIGH RESULTS FROM THE SUPPORT LABORATORY USING AN ALTERNATE METHOD. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROLACTIN (PRL) RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7128097 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K904714. One submission often covers many models, so check the product and lot details in each record.

• Z-2410-2012 · Aug 7, 2012 · Terminated
  ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usa
• Z-2409-2012 · Aug 7, 2012 · Terminated
  ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 0065