ADVIA Centaur® Total hCG (ThCG) 10331723Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00630414505183), received between Feb 9, 2018 and Feb 4, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025High Test Results; High Test Results

  THE CUSTOMER REPORTS OBSERVATION OF AN ELEVATED ADVIA CENTAUR TOTAL HCG (THCG) RESULT WITH LOT#: 361 WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL ELEVATED RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THIS RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND OBTAINED A LOWER RESULT WHICH WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS ISSUED BASED ON REPEAT TESTING. THERE IS NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21302037 ↗
• MalfunctionOct 14, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED OBSERVATION OF ADVIA CENTAUR CP TOTAL HCG (THCG) DISCORDANT (ELEVATED) PATIENT RESULTS WITH REAGENT LOT 357. INITIAL RESULTS WERE REPORTED, AND A PHYSICIAN QUESTIONED A RESULT. THE PATIENT SAMPLES WERE RETESTED ON A DIFFERENT ADVIA CENTAUR CP INSTRUMENT AND ALL RESULTS WERE LOWER AND CORRECTED REPORTS WERE ISSUED FOR (B)(4) SAMPLES. THE CUSTOMER FOUND THAT QUALITY CONTROL WAS IN RANGE BEFORE INITIALLY TESTING THE PATIENT SAMPLES, BUT AS PER THEIR LAB PROTOCOL, ONE QC LEVEL (L3) WAS RUN AFTER PATIENTS, AND IT WAS JUST OUTSIDE OF RANGE. THE PATIENT RESULTS HAD BEEN RELEASED BECAUSE IT WAS CONSIDERED ACCEPTABLE. THE INITIAL INSTRUMENT WAS RE-CALIBRATED, AND SAMPLES WERE RETESTED AND WERE LOWER THAN THE INITIAL RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446709 ↗
• MalfunctionFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT POSITIVE ADVIA CENTAUR XP TOTAL HCG RESULT WAS OBTAINED FOR A PATIENT SAMPLE. A SECOND SPECIMEN FROM THE SAME DRAW WAS TESTED AND THE RESULT WAS NEGATIVE. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. NO CORRECTED REPORT WAS ISSUED. THE PATIENT IS UNDERGOING ACNE TREATMENTS AND TAKING ACUTAINE. IT IS UNKNOWN IF THE PATIENT IS PREGNANT OR NOT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260735 ↗
• MalfunctionFeb 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT POSITIVE ADVIA CENTAUR XP TOTAL HCG RESULT WAS OBTAINED FOR A PATIENT SAMPLE. REPEAT TESTING WAS PERFORMED ON THE SECOND ADVIA CENTAUR XP AND THE RESULT WAS POSITIVE. A SECOND SPECIMEN FROM THE SAME DRAW WAS TESTED ON THE SECOND ADVIA CENTAUR XP INSTRUMENT AND THE RESULT WAS NEGATIVE. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. NO CORRECTED REPORT WAS ISSUED. THE PATIENT IS UNDERGOING ACNE TREATMENTS AND TAKING ACUTAINE. IT IS UNKNOWN IF THE PATIENT IS PREGNANT OR NOT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOTAL HCG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7260730 ↗