ADVIA Centaur® PRL 10309975Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414177267), received between Oct 22, 2020 and Oct 22, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2020Low Test Results; Low Test Results

  A FALSE LOW ADVIA CENTAUR XP PROLACTIN (PRL) RESULT WAS OBTAINED ON A PATIENT AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE PHYSICIAN WAS EXPECTING A HIGHER PROLACTIN RESULT. THE CUSTOMER PERFORMED REPEAT NEAT (UNDILUTED) TESTING OF THE SAMPLE, RESULTING LOW. FURTHER SAMPLE DILUTIONS WERE PERFORMED AND THE PRL RESULTS INCREASED AS THE DILUTION FACTOR INCREASED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ADVIA CENTAUR PROLACTIN (PRL) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10722397 ↗
• MalfunctionOct 22, 2020Low Test Results; Low Test Results

  A FALSE LOW ADVIA CENTAUR XP PROLACTIN (PRL) RESULT WAS OBTAINED ON A PATIENT AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE PHYSICIAN WAS EXPECTING A HIGHER PROLACTIN RESULT. THE CUSTOMER PERFORMED REPEAT NEAT (UNDILUTED) TESTING OF THE SAMPLE, RESULTING LOW. FURTHER SAMPLE DILUTIONS WERE PERFORMED, AND THE PRL RESULTS INCREASED AS THE DILUTION FACTOR INCREASED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED, PRESCRIBED, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ADVIA CENTAUR PROLACTIN (PRL) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10722395 ↗
• MalfunctionOct 22, 2020Low Test Results; Low Test Results

  A FALSE LOW ADVIA CENTAUR XP PROLACTIN (PRL) RESULT WAS OBTAINED ON A PATIENT AND THE REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN(S). THE PHYSICIAN WAS EXPECTING A HIGHER PROLACTIN RESULT. THE CUSTOMER PERFORMED REPEAT NEAT (UNDILUTED) TESTING OF THE SAMPLE, RESULTING LOW. FURTHER SAMPLE DILUTIONS WERE PERFORMED AND THE PRL RESULTS INCREASED AS THE DILUTION FACTOR INCREASED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, LOW ADVIA CENTAUR PROLACTIN (PRL) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10722393 ↗

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-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
• 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