ADVIA Centaur® Rub G 10310283Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00630414201412), received between Jul 21, 2017 and Nov 5, 2024 — classified as 16 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE (POSITIVE) ADVIA CENTAUR RUBELLA G (RUB G) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING RUB G LOT 251. THE CUSTOMER NOTICED A CHANGE IN SLOPE (FROM A HIGH NEAR 1.6 TO A LOWER VALUE CLOSE TO 1.0) AND A SHIFT IN QUALITY CONTROL (QC) RESULTS WHEN THE RUB G ASSAY WAS RECALIBRATED. SAMPLES WHICH HAD BEEN RUN WHEN THE SLOPE WAS HIGHER WERE REPEAT-TESTED WHEN THE SLOPE WAS CLOSER TO 1.0. SIX (6) SAMPLES WERE RE-TESTED USING THE SAME ANALYZER. REPEAT RESULTS FOR THESE SAMPLES WERE LOWER, WITH ONE INITIALLY REACTIVE SAMPLE PRODUCING AN EQUIVOCAL RESULT UPON REPEAT; NO CLINICAL DISCORDANCE WAS IDENTIFIED. THE CUSTOMER WAS UNCOMFORTABLE WITH THE OBSERVED VARIATION IN SLOPE FOR THE RUB G REAGENT LOT, AND CEASED USE OF THE ADVIA CENTAUR RUB G ASSAY. ADDITIONAL SAMPLES WERE SENT FOR RE-TEST TO AN EXTERNAL LABORATORY, WHERE AN ALTERNATE METHOD WAS USED. THESE 11 SAMPLES PRODUCED LOWER RESULTS WHEN RE-TESTED USING THE ALTERNATE METHOD; TWO SAMPLES WHICH HAD INITIALLY PRODUCED REACTIVE ADVIA CENTAUR RUB G RESULTS PRODUCED NONREACTIVE (NEGATIVE) RESULTS UPON RE-TEST. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612912 ↗
• MalfunctionSep 28, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTED OBSERVATION OF A POSITIVE ADVIA CENTAUR RUBELLA G (RUB G) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE INITIAL ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS SENT TO AN EXTERNAL REFERENCE LAB, AND A NEGATIVE RESULT WAS RETURNED. THIS RESULT WAS ACCEPTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17831088 ↗
• MalfunctionNov 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE RESULT WAS OBTAINED ON A PATIENT SAMPLE WITH ADVIA CENTAUR XPT FOR RUBELLA G (RUB G). THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A SECOND SAMPLE WAS COLLECTED FROM THE SAME PATIENT AND SENT TO AN ALTERNATE LABORATORY WHERE A NEGATIVE RUB G RESULT AND A POSITIVE RUBEOLA RESULT WERE OBTAINED USING UNKNOWN TEST METHODS. A THIRD SAMPLE WAS COLLECTED FROM THE SAME PATIENT AND TESTED FOR RUB G ON THE SAME ADVIA CENTAUR XPT INSTRUMENT AND A POSITIVE RESULT WAS REPRODUCED. COMPLAINT INFORMATION INDICATED THAT CALIBRATION AND QUALITY CONTROL RESULTS WERE IN RANGE, BUT NO DATA WAS PROVIDED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE RUBELLA G RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9338729 ↗
• MalfunctionNov 18, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE RESULT WAS OBTAINED ON A PATIENT SAMPLE WITH ADVIA CENTAUR XPT FOR RUBELLA G (RUB G). THE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A SECOND SAMPLE WAS COLLECTED FROM THE SAME PATIENT AND SENT TO AN ALTERNATE LABORATORY WHERE A NEGATIVE RUB G RESULT AND A POSITIVE RUBEOLA RESULT WERE OBTAINED USING UNKNOWN TEST METHODS. A THIRD SAMPLE WAS COLLECTED FROM THE SAME PATIENT AND TESTED FOR RUB G ON THE SAME ADVIA CENTAUR XPT INSTRUMENT AND A POSITIVE RESULT WAS REPRODUCED. COMPLAINT INFORMATION INDICATED THAT CALIBRATION AND QUALITY CONTROL RESULTS WERE IN RANGE, BUT NO DATA WAS PROVIDED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE RUBELLA G RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9338726 ↗
• MalfunctionApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE PHYSICIAN QUESTIONED THE POSITIVE RESULT. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS PREGNANT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524859 ↗
• MalfunctionApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE PHYSICIAN QUESTIONED THE POSITIVE RESULT. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS PREGNANT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524846 ↗
• MalfunctionApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE PHYSICIAN QUESTIONED THE POSITIVE RESULT. A CORRECTED REPORT WAS ISSUED. THE PATIENT IS PREGNANT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524834 ↗
• MalfunctionOct 29, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED ON A PREGNANT FEMALE, AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE RUBELLA G POSITIVE RESULT WAS CONSIDERED DISCORDANT COMPARED TO A NEGATIVE HISTORICAL RUBELLA G ALTERNATE TEST METHOD RESULT. A NEW SAMPLE WAS OBTAINED FROM THE SAME PATIENT AT A LATER DATE, RUN ON THE SAME ADVIA CENTAUR XP INSTRUMENT, DIFFERENT REAGENT LOT (068204), AND THE RUBELLA G RESULT WAS POSITIVE. THIS NEW SAMPLE WAS SENT TO THREE ALTERNATE SUPPORT LABORATORIES, TESTED ON ALTERNATE RUBELLA G TEST METHODS, AND THE RESULTS WERE ALL NEGATIVE. A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP RUBELLA IGG RESULTS. MDR 1219913-2018-00263 WAS FILED FOR A FALSE POSITIVE RESULT FOR THE SAME PATIENT ON ANOTHER REAGENT LOT (068202).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015538 ↗
• MalfunctionOct 29, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED ON A PREGNANT FEMALE, AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE RUBELLA G POSITIVE RESULT WAS CONSIDERED DISCORDANT COMPARED TO A NEGATIVE HISTORICAL RUBELLA G ALTERNATE TEST METHOD RESULT. A NEW SAMPLE WAS OBTAINED FROM THE SAME PATIENT AT A LATER DATE, RUN ON THE SAME ADVIA CENTAUR XP INSTRUMENT, DIFFERENT REAGENT LOT (068204), AND THE RUBELLA G RESULT WAS POSITIVE. THIS NEW SAMPLE WAS SENT TO THREE ALTERNATE SUPPORT LABORATORIES, TESTED ON ALTERNATE RUBELLA G TEST METHODS, AND THE RESULTS WERE ALL NEGATIVE. A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP RUBELLA IGG RESULTS. MDR 1219913-2018-00264 WAS FILED FOR A FALSE POSITIVE RESULT FOR THE SAME PATIENT, NEW SAMPLE, AND TESTED ON ANOTHER REAGENT LOT (068204).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8015528 ↗
• MalfunctionOct 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED ON A PATIENT SAMPLE, AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN BASED ON THE PATIENT'S NEGATIVE RUBELLA G TEST HISTORY. A SECOND SAMPLE WAS TESTED BY THE CUSTOMER, AND THE RUBELLA G RESULT WAS EQUIVOCAL. THE ORIGINAL SAMPLE WAS RETESTED, AND THE RUBELLA G RESULT WAS EQUIVOCAL. A CORRECTED REPORT WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE ADVIA CENTAUR XP RUBELLA IGG RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7947990 ↗
• MalfunctionOct 8, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  FALSE POSITIVE ADVIA CENTAUR XPT RUBELLA G (RUB G) RESULTS WERE OBTAINED ON A PATIENT SAMPLE FROM TWO DIFFERENT REAGENT LOTS. THE POSITIVE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO NEGATIVE RUBELLA G ALTERNATE TEST METHOD RESULT(S) DURING THE PATIENT'S PREGNANCY. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE ADVIA CENTAUR XPT RUBELLA IGG RESULTS. MDR 1219913-2018-00246 WAS FILED FOR AN INITIAL FALSE POSITIVE RESULT FROM THE SAME PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7945061 ↗
• MalfunctionOct 8, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  FALSE POSITIVE ADVIA CENTAUR XPT RUBELLA G (RUB G) RESULTS WERE OBTAINED ON A PATIENT SAMPLE FROM TWO DIFFERENT REAGENT LOTS. THE POSITIVE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO NEGATIVE RUBELLA G ALTERNATE TEST METHOD RESULT(S) DURING THE PATIENT'S PREGNANCY. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE ADVIA CENTAUR XPT RUBELLA IGG RESULTS. MDR 1219913-2018-00247 WAS FILED FOR A FALSE POSITIVE RESULT FROM THE SAME PATIENT IN SEPTEMBER, 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7945060 ↗
• MalfunctionSep 4, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED AN ELEVATED ADVIA CENTAUR XP RUBELLA IGG (RUBG) RESULT COMPARED TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR RUBELLA IGG RESULT. THE PATIENT WAS REDRAWN AND WILL LIKELY RECEIVE A BOOSTER FOR RUBELLA. MDR 1219913-2018-00213 WAS FILED FOR ELEVATED ADVIA CENTAUR XP RUBELLA G RESULTS WHEN COMPARED TO AN ALTERNATE METHOD FROM THE SAME PATIENT IN (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841908 ↗
• MalfunctionSep 4, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR XP RUBELLA IGG (RUBG) RESULTS COMPARED TO AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR RUBELLA IGG RESULTS. THE PATIENT WAS REDRAWN AND WILL LIKELY RECEIVE A BOOSTER FOR RUBELLA. MDR 1219913-2018-00212 WAS FILED FOR ELEVATED ADVIA CENTAUR XP RUBELLA G RESULTS WHEN COMPARED TO AN ALTERNATE METHOD FROM THE SAME PATIENT IN (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7841897 ↗
• MalfunctionNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE POSITIVE ADVIA CENTAUR CP RUBELLA G (RUB G) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS SENT TO A REFERENCE LABORATORY (NPL) AND THE RUBELLA G RESULT WAS NON-REACTIVE. IN GENERAL, THE CUSTOMER PERFORMS DUPLICATE TESTING OF SAMPLES, AND WILL REPORT A RESULT IF THEY ARE THE SAME. THE NON-REACTIVE RESULT FROM THE REFERENCE LABORATORY WAS REPORTED TO THE PROVIDED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7001357 ↗
• MalfunctionJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G (RUB G) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON ANOTHER ADVIA CENTAUR XP WHEN THE QUALITY CONTROL WAS RUN AND WAS OUT OF RANGE AT A LATER TIME. THE RESULT FOR THE PATIENT SAMPLE WAS EQUIVOCAL. A CORRECTED REPORT WAS ISSUED. THE REAGENT READYPACK WAS REPLACED AND THE ASSAY RECALIBRATED ON THE INITIAL ADVIA CENTAUR XP AS A RECOMMENDATION FROM SIEMENS. THE QUALITY CONTROL WAS RUN AND WAS IN RANGE. THE PATIENT SAMPLE WAS REPEATED AFTER THE QUALITY CONTROL WAS IN RANGE AND THE RESULT WAS EQUIVOCAL. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RUBELLA G RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731744 ↗