ADVIA Centaur® Toxo M 10310320Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00630414208442), received between Dec 11, 2017 and Mar 1, 2019 — classified as 8 malfunctions.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  FALSE POSITIVE (REACTIVE) ADVIA CENTAUR XPT TOXOPLASMA M (TOXO M) RESULT WAS OBTAINED FROM A (B)(6) YEAR OLD FEMALE WHO WAS (B)(6) PREGNANT. THE EXPECTED RESULT WAS NON-REACTIVE. THE SAME SAMPLE WAS SENT TO ANOTHER REFERENCE LABORATORY AND TESTED WITH AN ALTERNATE METHOD AND A NON-REACTIVE RESULT WAS OBTAINED. THE SAMPLE WAS ALSO TESTED WITH THE TOXO AVIDEZ (TOXO IGG AVIDITY) METHOD WITH A RESULT OF 79.28%. A NEW SAMPLE WAS DRAWN AND TESTED ON THE CUSTOMER'S CURRENT ADVIA CENTAUR XPT CALIBRATION AND AFTER RECALIBRATION; BOTH RESULTS WERE REACTIVE. THE SAME SAMPLE WAS SENT TO ANOTHER REFERENCE LABORATORY AND TESTED ON THE ADVIA CENTAUR XPT AND A REACTIVE RESULT WAS OBTAINED. CUSTOMER STATED THAT THE PATIENT WAS ADMINISTERED MEDICATIONS (ANEMIDOX, GESTAVI, GLYCOPEM) BASED ON THE TOXO AVIDITY RESULT AND THE REACTIVE ADVIA CENTAUR RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT TOXO M RESULT.

  Patient problems: No Code Available

  MAUDE report 8381807 ↗
• MalfunctionMar 1, 2019No Apparent Adverse Event; No Apparent Adverse Event

  FALSE POSITIVE (REACTIVE) ADVIA CENTAUR XPT TOXOPLASMA M (TOXO M) RESULT WAS OBTAINED FROM A (B)(6) YEAR OLD FEMALE WHO WAS (B)(6) PREGNANT. THE EXPECTED RESULT WAS NON-REACTIVE. THE SAME SAMPLE WAS SENT TO ANOTHER REFERENCE LABORATORY AND TESTED WITH AN ALTERNATE METHOD AND A NON-REACTIVE RESULT WAS OBTAINED. THE SAMPLE WAS ALSO TESTED WITH THE TOXO AVIDEZ (TOXO IGG AVIDITY) METHOD WITH A RESULT OF 79.28%. A NEW SAMPLE WAS DRAWN AND TESTED ON THE CUSTOMER'S CURRENT ADVIA CENTAUR XPT CALIBRATION AND AFTER RECALIBRATION; BOTH RESULTS WERE REACTIVE. THE SAME SAMPLE WAS SENT TO ANOTHER REFERENCE LABORATORY AND TESTED ON THE ADVIA CENTAUR XPT AND A REACTIVE RESULT WAS OBTAINED. CUSTOMER STATED THAT THE PATIENT WAS ADMINISTERED MEDICATIONS (ANEMIDOX, GESTAVI, GLYCOPEM) BASED ON THE TOXO AVIDITY RESULT AND THE REACTIVE ADVIA CENTAUR RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT TOXO M RESULT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 8381806 ↗
• MalfunctionMay 18, 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 NEGATIVE ADVIA CENTAUR XPT TOXOPLASMA M (TOXO M) RESULTS WERE OBTAINED WITH A NEW REAGENT LOTS (080290, 080291) RECEIVED BY THE CUSTOMER WHEN PERFORMING A COMPARISON STUDY WITH A PREVIOUSLY USED REAGENT LOT (080288). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE ADVIA CENTAUR XPT TOXOPLASMA M COMPARISON STUDY RESULTS. MDR 1219913-2018-00155 WAS FILED FOR FALSE NEGATIVE COMPARISON STUDY RESULTS WITH REAGENT LOT (080291) ADVIA CENTAUR XPT 1, AND MDR 1219913-2018-00156 WAS FILED FOR SIMILAR FALSE NEGATIVE RESULTS WITH REAGENT LOT (080291) ADVIA CENTAUR XPT 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527410 ↗
• MalfunctionMay 18, 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 NEGATIVE ADVIA CENTAUR XPT TOXOPLASMA M (TOXO M) RESULTS WERE OBTAINED WITH A NEW REAGENT LOTS (080290, 080291) RECEIVED BY THE CUSTOMER WHEN PERFORMING A COMPARISON STUDY WITH A PREVIOUSLY USED REAGENT LOT (080288). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE ADVIA CENTAUR XPT TOXOPLASMA M COMPARISON STUDY RESULTS. MDR 1219913-2018-00154 WAS FILED FOR FALSE NEGATIVE COMPARISON STUDY RESULTS WITH REAGENT LOT (080290), AND MDR 1219913-2018-00156 WAS FILED FOR SIMILAR FALSE NEGATIVE RESULTS WITH REAGENT LOT (080291) ADVIA CENTAUR XPT 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527409 ↗
• MalfunctionMay 18, 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 NEGATIVE ADVIA CENTAUR XPT TOXOPLASMA M (TOXO M) RESULTS WERE OBTAINED WITH A NEW REAGENT LOTS (080290, 080291) RECEIVED BY THE CUSTOMER WHEN PERFORMING A COMPARISON STUDY WITH A PREVIOUSLY USED REAGENT LOT (080288). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE NEGATIVE ADVIA CENTAUR XPT TOXOPLASMA M COMPARISON STUDY RESULTS. MDR 1219913-2018-00154 WAS FILED FOR FALSE NEGATIVE COMPARISON STUDY RESULTS WITH REAGENT LOT (080290), AND MDR 1219913-2018-00155 WAS FILED FOR SIMILAR FALSE NEGATIVE RESULTS WITH REAGENT LOT (080291) ADVIA CENTAUR XPT 1.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7527408 ↗
• MalfunctionMay 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE NEGATIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT KNOWN TO BE PREGNANT. THE PATIENT WAS INITIALLY TESTED FOR TOXOPLASMA M AT AN ALTERNATE LABORATORY AND TEST METHOD THAT RESULTED POSITIVE. BASED ON THE ALTERNATE LABORATORY POSITIVE RESULT, A NEW SAMPLE WAS DRAWN, TESTED ON THE ADVIA CENTAUR XP BY THIS CUSTOMER, AND THE TOXOPLASMA M RESULT WAS NEGATIVE. A NEW SAMPLE WAS DRAWN AND TESTED AT SECOND ALTERNATE LABORATORY, AND THE TOXOPLASMA M RESULT WAS POSITIVE. A NEW SAMPLE WAS DRAWN AND TESTED AT A THIRD INSTITUTION (HOSPITAL) WHICH IS AN UNIVERSITY LAB, AND THE TOXOPLASMA M RESULT WAS POSITIVE. BASED ON THE POSITIVE TOXOPLASMA M RESULT FROM THE THIRD INSTITUTION (HOSPITAL) AND UNIVERSITY LAB, "THE BABY WAS ABOLISHED". THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TOXOPLASMA M RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7484512 ↗
• MalfunctionDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NEGATIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT KNOWN TO BE PREGNANT. THE NEGATIVE TOXO M RESULT WAS CONSIDERED DISCORDANT COMPARED TO AN EARLIER POSITIVE REFERENCE LABORATORY TOXOPLASMA IGM TEST METHOD RESULT. THE PATIENT SAMPLE WAS SENT TO THE REFERENCE LABORATORY FOR FURTHER TESTING. THE NEGATIVE ADVIA CENTAUR XP TOXO M RESULT WAS NOT REPORTED. THE SAME PATIENT WAS TESTED EARLIER ((B)(6) 2017), AND THE ADVIA CENTAUR XP TOXO M RESULT WAS NEGATIVE COMPARED TO THE SAME REFERENCE LABORATORY POSITIVE RESULT (REFER TO MDR 1219913-2017-00255). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE ADVIA CENTAUR XP TOXO M RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7106834 ↗
• MalfunctionDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FALSE NEGATIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT KNOWN TO BE PREGNANT. THE NEGATIVE TOXO M RESULT CONSIDERED DISCORDANT COMPARED TO A POSITIVE REFERENCE LABORATORY TEST METHOD RESULT. THE PATIENT SAMPLE WAS SENT TO THE REFERENCE LABORATORY FOR FURTHER TESTING, AND THE TOXO M RESULT WAS POSITIVE. A CORRECTIVE REPORT WAS ISSUED. THE SAME PATIENT WAS REDRAWN AT A LATER DATE ((B)(6) 2017), AND THE ADVIA CENTAUR XP TOXO M RESULT WAS NEGATIVE (REFER TO MDR 1219913-2017-00256). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TOXO M RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7106826 ↗