ADVIA Centaur HCV 11203483Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414278759), received between Apr 4, 2024 and Jan 3, 2025 — classified as 3 malfunctions.

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

• MalfunctionJan 3, 2025False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF A NONREACTIVE (NEGATIVE) ADVIA CENTAUR HCV (AHCV) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AHCV REAGENT LOT#: 473 WAS IN USE AT THE TIME. AN INITIAL REACTIVE (POSITIVE) RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE SAME SAMPLE WAS RETESTED ON THE SAME ANALYZER AND OBTAINED A NONREACTIVE (NEGATIVE) RESULT. BOTH RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE NONREACTIVE (NEGATIVE) RESULT WAS CONSIDERED DISCORDANT BY THE CUSTOMER. THEREFORE, A FOLLOW-UP TESTING WAS PERFORMED FOR THE SAME SAMPLE IN DUPLICATE WHICH PRODUCED REACTIVE (POSITIVE) RESULTS. THE REACTIVE (POSITIVE) RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). 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 21065826 ↗
• MalfunctionOct 25, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS AN OBSERVATION OF A NON-REACTIVE (NEGATIVE) ADVIA CENTAUR HCV (AHCV) RESULT WHICH WAS CONSIDERED DISCORDANT RELATIVE TO CLINICAL EXPECTATION. AHCV REAGENT LOT# 466 WAS IN USE AT THE TIME. AN INITIAL REACTIVE (POSITIVE) RESULT WAS OBTAINED FOR THE PATIENT IN QUESTION. THE INITIAL REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). PER ADVIA CENTAUR HCV (AHCV) INSTRUCTIONS FOR USE (IFU), THE CUSTOMER PERFORMED A FOLLOW-UP TESTING WITH THE SAME SAMPLE, WHICH PRODUCED A NONREACTIVE (NEGATIVE) RESULT. THIS RESULT WAS CONSIDERED DISCORDANT BY THE CUSTOMER. THE SAME SAMPLE WAS THEN REPEATED IN DUPLICATE WHICH PRODUCED REACTIVE (POSITIVE) RESULTS SIMILAR TO THE INITIAL RESULT. THE REACTIVE RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S) AS IT MATCHED THE CLINICAL EXPECTATION FOR THE AFFECTED PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20531637 ↗
• MalfunctionApr 4, 2024False Negative Result; False Negative Result

  THE CUSTOMER REPORTS OBSERVATION OF NONREACTIVE ADVIA CENTAUR HCV (AHCV) RESULTS WHICH WERE DISCORDANT RELATIVE TO PATIENT HISTORY AND ALTERNATE-METHOD TESTING. AHCV REAGENT LOT 459 WAS IN USE AT THE TIME. TWO PATIENTS PRODUCED NONREACTIVE (NEGATIVE) RESULTS IN INITIAL TESTING. THE PHYSICIAN QUESTIONED THESE RESULTS BASED ON PATIENT HISTORY. THE SAMPLES WERE RE-TESTED IN DUPLICATE THE FOLLOWING DAY, AND BOTH PRODUCED REACTIVE (POSITIVE) RESULTS WHICH WERE ACCEPTED AS CORRECT. CORRECTIVE REPORTS WERE FILED FOR BOTH PATIENTS; THE PHYSICIAN STATES THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19040282 ↗