ADVIA Centaur® CHIV 10696880Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00630414589749), received between Jun 15, 2018 and Apr 5, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT AN EMPLOYEE IS BEING ADMINISTERED ANTI-VIRAL MEDICATION (PAP MED) AS A RESULT OF A NEEDLESTICK ASSOCIATED WITH A PATIENT DISPLAYING INCONSISTENT (B)(6) RESULTS BETWEEN THE ADVIA CENTAUR XP (B)(6) AG/AB COMBO (B)(6) ASSAY AND TWO ALTERNATE METHODS. THERE IS NO EVIDENCE THAT THE EMPLOYEE WHO EXPERIENCED THE NEEDLESTICK WAS TESTED FOR (B)(6). THERE IS NO INDICATION OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NEEDLESTICK OR THE ANTI-VIRAL MEDICATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8487270 ↗
• MalfunctionOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE (B)(6). THE SAMPLE WAS A "NEDDLSTICK" WITH A STAT CHIV TESTING REQUESTED. THE PATIENT SAMPLE WAS TESTED WITH A CONFIRMATORY ELISA METHOD AT ANOTHER LABORATORY AND THE RESULT WAS (B)(6). THE IN-HOUSE NEEDLESTICK RESULT WAS REPORTED AS (B)(6). THE PATIENT RECEIVED PROPHYLACTIC PEP TREATMENT DUE TO THE NEEDLESTICK. IT IS UNKNOWN IF THE TREATMENT WAS ADMINISTERED BEFORE THE SAMPLE WAS DRAWN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7986480 ↗
• MalfunctionOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE (B)(6). THE SAMPLE WAS A "NEDDLSTICK" WITH A STAT CHIV TESTING REQUESTED. THE PATIENT SAMPLE WAS TESTED WITH A CONFIRMATORY ELISA METHOD AT ANOTHER LABORATORY AND THE RESULT WAS (B)(6). THE IN-HOUSE NEEDLE STICK RESULT WAS REPORTED AS (B)(6) NOT CONFIRMED. THE PATIENT RECEIVED PROPHYLACTIC PEP TREATMENT DUE TO THE NEEDLESTICK. IT IS UNKNOWN IF THE TREATMENT WAS ADMINISTERED BEFORE THE SAMPLE WAS DRAWN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7986465 ↗
• MalfunctionJul 30, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A PATIENT SAMPLE WAS TESTED WITH ADVIA (B)(6) ASSAY THREE TIMES. THE RESULTS WERE (B)(6). THE OPERATOR MANUALLY VALIDATED THE THIRD (B)(6) RESULT THAT UPLOADED INTO CENTRALINK INSTEAD OF FOLLOWING GUIDELINES INSTRUCTING TO REVERT AND RELEASE THE FIRST (B)(6) RESULT. THE (B)(6) RESULT WAS NOT REPORTED TO THE DOCTOR. THE ERROR WAS CAUGHT BEFORE THE RESULT WAS SENT TO THE DOCTOR. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA (B)(6) RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731359 ↗
• MalfunctionJun 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS RESPUN AND REPEATED. THE RESULTS WERE REPEAT (B)(6). THE PATIENT SAMPLE WAS SENT OUT TO ANOTHER LABORATORY FOR CONFIRMATION TESTING. THE PATIENT SAMPLE WAS ALSO TESTED AT THE CUSTOMER SITE ON AN ALTERNATE METHOD. THE RESULTS WERE (B)(6). THE CUSTOMER REPORTS THE PATIENT TESTED FOR (B)(6) IS A (B)(6) YEAR OLD CHILD THAT WAS BEING TESTED DUE TO A MEDICAL PROFESSIONAL HAVING BEEN EXPOSED TO THAT CHILD'S BODILY FLUIDS DURING A MEDICAL OR DENTAL PROCEDURE. A CORRECTED REPORT WAS SENT TO THE PHYSICIAN TREATING THE MEDICAL PROFESSIONAL WHO WAS EXPOSED. THE MEDICAL PROFESSIONAL THAT WAS EXPOSED TO THE PATIENT'S BODILY FLUIDS WAS PRESCRIBED TO TAKE ANTIVIRAL MEDICATION FOR APPROXIMATELY THREE DAYS DUE TO THE (B)(6) RESULTS. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV.

  Patient problems: No Code Available

  MAUDE report 7624624 ↗
• MalfunctionJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULTS WERE OBTAINED ON A PATIENT, AND THE INITIAL REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS PREVIOUSLY TESTED FOR (B)(6) RNA BY PCR, AND THE RESULT WAS (B)(6). THE PHYSICIAN ORDERED A SECOND ADVIA CENTAUR XP CHIV TEST, AND THE RESULT WAS (B)(6). THE CUSTOMER PERFORMED REPLICATE (X3) TESTING OF DIFFERENT SAMPLE TUBE TYPES FROM THE SAME PATIENT, AND THE RESULTS WERE (B)(6) ON THE ADVIA CENTAUR XP. THE PATIENT SAMPLES WERE SENT OUT, TESTED ON THREE ALTERNATE (B)(6) TEST METHODS, AND THE RESULTS WERE ALL (B)(6). A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV RESULTS. MDR 1219913-2018-00169 WAS FILED FOR AN INITIAL RESULT, MDR 1219913-2018-00171 WAS FILED FOR REPEAT TESTING WITH A PLASMA SAMPLE, AND MDR 1219913-2018-00175 WAS FILED FOR A REORDER RESULT FROM THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606978 ↗
• MalfunctionJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULTS WERE OBTAINED ON A PATIENT, AND THE INITIAL REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS PREVIOUSLY TESTED FOR (B)(6) BY PCR, AND THE RESULT WAS (B)(6). THE PHYSICIAN ORDERED A SECOND ADVIA CENTAUR XP CHIV TEST, AND THE RESULT WAS (B)(6). THE CUSTOMER PERFORMED REPLICATE (X3) TESTING OF DIFFERENT SAMPLE TUBE TYPES FROM THE SAME PATIENT, AND THE RESULTS WERE (B)(6) ON THE ADVIA CENTAUR XP. THE PATIENT SAMPLES WERE SENT OUT, TESTED ON THREE ALTERNATE HIV TEST METHODS, AND THE RESULTS WERE ALL (B)(6). A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV RESULTS. MDR 1219913-2018-00170, AND MDR 1219913-2018-00171 WERE FILED FOR REPEAT TESTING WITH SERUM AND PLASMA SAMPLES ON A DIFFERENT DAY, AND MDR 1219913-2018-00175 WAS FILED FOR A REORDER RESULT FROM A DIFFERENT DAY FROM THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606976 ↗
• MalfunctionJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULTS WERE OBTAINED ON A PATIENT, AND THE INITIAL REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS PREVIOUSLY TESTED FOR (B)(6) BY PCR, AND THE RESULT WAS (B)(6). THE PHYSICIAN ORDERED A SECOND ADVIA CENTAUR XP CHIV TEST, AND THE RESULT WAS (B)(6). THE CUSTOMER PERFORMED REPLICATE (X3) TESTING OF DIFFERENT SAMPLE TUBE TYPES FROM THE SAME PATIENT, AND THE RESULTS WERE (B)(6) ON THE ADVIA CENTAUR XP. THE PATIENT SAMPLES WERE SENT OUT, TESTED ON THREE ALTERNATE HIV TEST METHODS, AND THE RESULTS WERE ALL (B)(6). A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV RESULTS. MDR 1219913-2018-00169 WAS FILED FOR AN INITIAL RESULT, AND MDR 1219913-2018-00170 WAS FILED FOR REPEAT TESTING WITH A SERUM SAMPLE, AND MDR 1219913-2018-00175 WAS FILED FOR A REORDER RESULT FROM THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606975 ↗
• MalfunctionJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULTS WERE OBTAINED ON A PATIENT, AND THE INITIAL REPORTED RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS PREVIOUSLY TESTED FOR (B)(6) BY PCR, AND THE RESULT WAS (B)(6). THE PHYSICIAN ORDERED A SECOND ADVIA CENTAUR XP CHIV TEST, AND THE RESULT WAS (B)(6). THE CUSTOMER PERFORMED REPLICATE (X3) TESTING OF DIFFERENT SAMPLE TUBE TYPES FROM THE SAME PATIENT, AND THE RESULTS WERE (B)(6) ON THE ADVIA CENTAUR XP. THE PATIENT SAMPLES WERE SENT OUT, TESTED ON THREE ALTERNATE (B)(6) TEST METHODS, AND THE RESULTS WERE ALL (B)(6). A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV RESULTS. MDR 1219913-2018-00169 WAS FILED FOR AN INITIAL RESULT, MDR 1219913-2018-00170 AND MDR 1219913-2018-00171 WERE FILED FOR REPEAT TESTING WITH SERUM AND PLASMA SAMPLES FROM THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606974 ↗