ADVIA Centaur® Toxo G 10310321Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00630414208459), received between Jul 21, 2017 and Jun 24, 2025 — classified as 68 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (27 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 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTED AN OBSERVATION OF A REACTIVE (POSITIVE) ADVIA CENTAUR TOXOPLASMA G (TOXO G) RESULT WHICH WAS CONSIDERED DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING REAGENT LOT#296. AN INITIAL REACTIVE RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAME SAMPLE WAS REPEATED ON THE ORIGINAL ADVIA CENTAUR XPT INSTRUMENT AND OBTAINED A NON-REACTIVE (NEGATIVE RESULT). THE NON-REACTIVE RESULT WAS CONSIDERED CORRECT AND ISSUED ON THE CORRECTED REPORT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF DELAY, PATIENT INTERVENTION, OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22317771 ↗
• MalfunctionMay 2, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLE FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULTS FOR ONE PATIENT. ELEVATED TOXO G RESULTS WERE OBSERVED FOR TWO SAMPLES FROM ONE 34-YEAR-OLD PREGNANT PATIENT. AN INITIAL POSITIVE TOXO G RESULT WAS REPORTED AND QUESTIONED AS DISCORDANT BY THE PHYSICIAN. REPEAT TESTING USING ANOTHER METHOD AT ANOTHER SITE PRODUCED A NEGATIVE RESULT, WHICH WAS REPORTED AND ACCEPTED AS CORRECT. THE SAME PATIENT WAS TESTED THREE WEEKS LATER, AND AGAIN PRODUCED A POSITIVE TOXO G RESULT, WHICH WAS QUESTIONED. REPEAT TESTING (USING THE SAME ALTERNATE METHOD) AGAIN PRODUCED A NEGATIVE RESULT, WHICH 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 16856096 ↗
• MalfunctionMay 2, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLE FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULTS FOR ONE PATIENT. ELEVATED TOXO G RESULTS WERE OBSERVED FOR TWO SAMPLES FROM ONE 34-YEAR-OLD PREGNANT PATIENT. AN INITIAL POSITIVE TOXO G RESULT WAS REPORTED AND QUESTIONED AS DISCORDANT BY THE PHYSICIAN. REPEAT TESTING USING ANOTHER METHOD AT ANOTHER SITE PRODUCED A NEGATIVE RESULT, WHICH WAS REPORTED AND ACCEPTED AS CORRECT. THE SAME PATIENT WAS TESTED THREE WEEKS LATER, AND AGAIN PRODUCED A POSITIVE TOXO G RESULT, WHICH WAS QUESTIONED. REPEAT TESTING (USING THE SAME ALTERNATE METHOD) AGAIN PRODUCED A NEGATIVE RESULT, WHICH 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 16856067 ↗
• MalfunctionApr 11, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) RESULT FOR ONE PATIENT THAT WAS CONSIDERED DISCORDANT WITH THE NONREACTIVE (NEGATIVE) RESULTS FROM TWO ALTERNATE METHODS. THE REACTIVE RESULT WAS NOT REPORTED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT TOXO G RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714062 ↗
• MalfunctionNov 2, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A DISCORDANT REACTIVE TOXOPLASMA G (TOXO G) PATIENT RESULT ON THE ADVIA CENTAUR XPT. ON REPEATING THE SAMPLE ON THE SAME ADVIA CENTAUR XPT, THE RESULT WAS REACTIVE. A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS ALSO REACTIVE. THE SAMPLE WAS TESTED ON AN ALTERNATE METHOD FOR TOXO G AND THE RESULT WAS NONREACTIVE (NEGATIVE). THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714212 ↗
• MalfunctionNov 2, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A DISCORDANT REACTIVE TOXOPLASMA G (TOXO G) PATIENT RESULT ON THE ADVIA CENTAUR XPT. ON REPEATING THE SAMPLE ON THE SAME ADVIA CENTAUR XPT, THE RESULT WAS REACTIVE. A SECOND SAMPLE FROM THE SAME PATIENT WAS TESTED AND THE RESULT WAS ALSO REACTIVE. THE SAMPLE WAS TESTED ON AN ALTERNATE METHOD FOR TOXO G AND THE RESULT WAS NONREACTIVE (NEGATIVE). THE RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS IN ASSOCIATION WITH THE DISCORDANT TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714111 ↗
• MalfunctionApr 15, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLY FALSE-POSITIVE ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) RESULTS FOR ONE PATIENT. AN INITIAL REACTIVE (POSITIVE) ADVIA CENTAUR XPT TOXO G RESULT WAS OBTAINED USING KIT LOT 277. TOXOPLASMA IGM AND AVIDITY TESTS WERE NEGATIVE. THE TOXO G RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS RE-TESTED USING THE SAME METHOD ON THE FOLLOWING DAY, AND PRODUCED ANOTHER POSITIVE RESULT. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO ANOTHER LABORATORY, WHERE NEGATIVE TOXOPLASMA IGG RESULTS WERE OBTAINED USING TWO ALTERNATE TEST METHODS. THE NEGATIVE RESULTS WERE CONCORDANT WITH THE OBSERVED AVIDITY TEST RESULT, AND WERE ACCEPTED AS CORRECT. THERE ARE NO REPORTS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS RESULTING FROM THE OBSERVED DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119440 ↗
• MalfunctionApr 15, 2022False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REPRODUCIBLY FALSE-POSITIVE ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) RESULTS FOR ONE PATIENT. AN INITIAL REACTIVE (POSITIVE) ADVIA CENTAUR XPT TOXO G RESULT WAS OBTAINED USING KIT LOT 277. TOXOPLASMA IGM AND AVIDITY TESTS WERE NEGATIVE. THE TOXO G RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS RE-TESTED USING THE SAME METHOD ON THE FOLLOWING DAY, AND PRODUCED ANOTHER POSITIVE RESULT. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO ANOTHER LABORATORY, WHERE NEGATIVE TOXOPLASMA IGG RESULTS WERE OBTAINED USING TWO ALTERNATE TEST METHODS. THE NEGATIVE RESULTS WERE CONCORDANT WITH THE OBSERVED AVIDITY TEST RESULT, AND WERE ACCEPTED AS CORRECT. THERE ARE NO REPORTS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS IN DIAGNOSIS RESULTING FROM THE OBSERVED DISCORDANT RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119437 ↗
• MalfunctionJul 2, 2021False Positive Result; False Positive Result

  A CUSTOMER OBTAINED A REACTIVE (POSITIVE) PATIENT RESULT WITH THE ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY. THE REACTIVE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE NON-REACTIVE (NEGATIVE) RESULTS OBTAINED WHEN THE SAMPLE WAS RETESTED ON TWO (2) ALTERNATE METHODS. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXO G RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112393 ↗
• MalfunctionMay 13, 2021False Positive Result; False Positive Result

  A FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) RESULT WAS OBTAINED BY THE CUSTOMER. THE SAME PATIENT SAMPLE WAS REPEATED ON AN ATELLICA IM SYSTEM, RESULTING POSITIVE. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE WITH TWO ALTERNATE TOXOPLASMA G TEST METHODS, RESULTING NEGATIVE. A NEGATIVE TOXOPLASMA G RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE ADVIA CENTAUR AND ATELLICA IM TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822950 ↗
• MalfunctionMar 17, 2021False Positive Result; False Positive Result

  A DISCORDANT REACTIVE (POSITIVE) RESULT WAS OBSERVED FOR ONE PATIENT WHEN USING THE ADVIA CENTAUR TOXOPLASMA G ASSAY. THIS REACTIVE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE WITH TWO ALTERNATE TOXOPLASMA IGG TEST METHODS, PRODUCING NONREACTIVE (NEGATIVE) RESULTS, WHICH WERE REPORTED TO THE PHYSICIAN(S) AS CORRECT. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE-REACTIVE (POSITIVE) ADVIA CENTAUR® TOXOPLASMA G ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11508617 ↗
• MalfunctionFeb 18, 2021False Positive Result; False Positive Result

  A FALSE REACTIVE (POSITIVE) ADVIA CENTAUR® TOXOPLASMA G ASSAY RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE WITH TWO ALTERNATE TOXOPLASMA IGG TEST METHODS, RESULTING NONREACTIVE (NEGATIVE). A NONREACTIVE (NEGATIVE) TOXOPLASMA IGG RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE REACTIVE (POSITIVE) ADVIA CENTAUR® TOXOPLASMA G ASSAY RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345800 ↗
• MalfunctionDec 23, 2020False Positive Result; False Positive Result

  A FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULT WAS OBTAINED BY THE CUSTOMER AND THE REPORTED RESULT WAS QUESTION BY THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XPT AND RUN ON A SECOND ADVIA CENTAUR XPT, BOTH RESULTING POSITIVE. THE SAME SAMPLE WAS TESTED AGAIN ON THE FIRST ADVIA CENTAUR XPT WITH A DIFFERENT REAGENT LOT, RESULTING POSITIVE. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE WITH AN ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY, RUN ON THE SAME ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. A SECOND SAMPLE WAS TESTED AT AN ALTERNATE HOSPITAL FOR TOXOPLASMA IGG, RESULTING NEGATIVE. A NEGATIVE TOXOPLASMA IGG RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069572 ↗
• MalfunctionDec 23, 2020False Positive Result; False Positive Result

  A FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULT WAS OBTAINED BY THE CUSTOMER AND THE REPORTED RESULT WAS QUESTION BY THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XPT AND RUN ON A SECOND ADVIA CENTAUR XPT, BOTH RESULTING POSITIVE. THE SAME SAMPLE WAS TESTED AGAIN ON THE FIRST ADVIA CENTAUR XPT WITH A DIFFERENT REAGENT LOT, RESULTING POSITIVE. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE WITH AN ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY, RUN ON THE SAME ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. A SECOND SAMPLE WAS TESTED AT AN ALTERNATE HOSPITAL FOR TOXOPLASMA IGG, RESULTING NEGATIVE. A NEGATIVE TOXOPLASMA IGG RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069513 ↗
• MalfunctionDec 23, 2020False Positive Result; False Positive Result

  A FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULT WAS OBTAINED BY THE CUSTOMER AND THE REPORTED RESULT WAS QUESTION BY THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XPT AND RUN ON A SECOND ADVIA CENTAUR XPT, BOTH RESULTING POSITIVE. THE SAME SAMPLE WAS TESTED AGAIN ON THE FIRST ADVIA CENTAUR XPT WITH A DIFFERENT REAGENT LOT, RESULTING POSITIVE. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE WITH AN ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY, RUN ON THE SAME ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. A SECOND SAMPLE WAS TESTED AT AN ALTERNATE HOSPITAL FOR TOXOPLASMA IGG, RESULTING NEGATIVE. A NEGATIVE TOXOPLASMA IGG RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069488 ↗
• MalfunctionDec 23, 2020False Positive Result; False Positive Result

  A FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULT WAS OBTAINED BY THE CUSTOMER AND THE REPORTED RESULT WAS QUESTION BY THE PHYSICIAN(S). THE PATIENT SAMPLE WAS REPEATED ON THE SAME ADVIA CENTAUR XPT AND RUN ON A SECOND ADVIA CENTAUR XPT, BOTH RESULTING POSITIVE. THE SAME SAMPLE WAS TESTED AGAIN ON THE FIRST ADVIA CENTAUR XPT WITH A DIFFERENT REAGENT LOT, RESULTING POSITIVE. THE CUSTOMER PERFORMED REPEAT TESTING ON THE SAME SAMPLE WITH AN ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY, RUN ON THE SAME ALTERNATE TOXOPLASMA IGG TEST METHOD, RESULTING NEGATIVE. A SECOND SAMPLE WAS TESTED AT AN ALTERNATE HOSPITAL FOR TOXOPLASMA IGG, RESULTING NEGATIVE. A NEGATIVE TOXOPLASMA IGG RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069471 ↗
• MalfunctionDec 4, 2020False Positive Result; False Positive Result

  ON (B)(6) 2020, A DISCORDANT POSITIVE (REACTIVE) ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) RESULT WAS OBSERVED FOR ONE PATIENT. THE RESULT WAS CONSIDERED DISCORDANT RELATIVE TO NEGATIVE RESULTS OBTAINED USING TWO ALTERNATE TESTING METHODS. THESE NEGATIVE RESULTS WERE ACCEPTED AS CORRECT. THE PATIENT IN QUESTION HAD RECENTLY GIVEN BIRTH WHEN THE DISCORDANT RESULT WAS OBTAINED. THE SAME PATIENT HAD TESTED NEGATIVE FOR TOXO G, WHILE PREGNANT, IN (B)(6) 2019. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10944323 ↗
• MalfunctionOct 14, 2020False Positive Result; False Positive Result

  A CUSTOMER OBTAINED REACTIVE (POSITIVE) RESULTS ON TWO SAMPLES FROM THE SAME PATIENT USING THE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY. THESE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE NON-REACTIVE (NEGATIVE) RESULTS OBTAINED WHEN THE SAMPLES WERE TESTED USING ALTERNATE METHODS. THE FIRST PATIENT SAMPLE WAS SENT TO AN ALTERNATE LABORATORY AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE SECOND SAMPLE WAS ALSO SENT OUT AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE POSITIVE ADVIA CENTAUR XP TOXO G RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. IT IS UNKNOWN IF A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10677644 ↗
• MalfunctionOct 14, 2020False Positive Result; False Positive Result

  A CUSTOMER OBTAINED REACTIVE (POSITIVE) RESULTS ON TWO SAMPLES FROM THE SAME PATIENT USING THE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY. THESE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE NON-REACTIVE (NEGATIVE) RESULTS OBTAINED WHEN THE SAMPLES WERE TESTED USING ALTERNATE METHODS. THE FIRST PATIENT SAMPLE WAS SENT TO AN ALTERNATE LABORATORY AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE SECOND SAMPLE WAS ALSO SENT OUT AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE POSITIVE ADVIA CENTAUR XP TOXO G RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. IT IS UNKNOWN IF A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10677643 ↗
• MalfunctionOct 14, 2020False Positive Result; False Positive Result

  A CUSTOMER OBTAINED REACTIVE (POSITIVE) RESULTS ON TWO SAMPLES FROM THE SAME PATIENT USING THE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY. THESE RESULTS WERE CONSIDERED DISCORDANT COMPARED TO THE NON-REACTIVE (NEGATIVE) RESULTS OBTAINED WHEN THE SAMPLES WERE TESTED USING ALTERNATE METHODS. THE FIRST PATIENT SAMPLE WAS SENT TO AN ALTERNATE LABORATORY AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE SECOND SAMPLE WAS ALSO SENT OUT AND PROCESSED ON AN ALTERNATE METHOD; A NEGATIVE RESULT WAS OBTAINED. THE POSTIVE ADVIA CENTAUR XP TOXO G RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. IT IS UNKNOWN IF A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10677642 ↗
• MalfunctionOct 6, 2020False Positive Result; False Positive Result

  A CUSTOMER OBTAINED A FALSE POSITIVE RESULT ON A PATIENT SAMPLE USING THE ADVIA CENTAUR XP TOXOPLASMA IGG (TOXO G) ASSAY. THE SAME SAMPLE WAS RETESTED WITH THE SAME REAGENT LOT. THESE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. A NEGATIVE RESULT WAS OBTAINED WHEN THE SAMPLE WAS TESTED WITH AN ALTERNATE METHOD, WHICH WAS REPORTED TO THE PHYSICIAN. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10639665 ↗
• MalfunctionAug 28, 2020False Positive Result; False Positive Result

  A CUSTOMER REPORTED THAT MULTIPLE PATIENT SAMPLES WERE RETESTED BECAUSE MANY RESULTS HAD HIGH VALUES (FALSE POSITIVE) FROM THE INITIAL TESTING USING ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G). THE CUSTOMER BELIEVES THAT ALL OF THE INITIAL POSITIVE RESULTS ARE FALSE POSITIVE. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10469236 ↗
• MalfunctionAug 28, 2020False Positive Result; False Positive Result

  A CUSTOMER REPORTED THAT MULTIPLE PATIENT SAMPLES WERE RETESTED BECAUSE MANY RESULTS HAD HIGH VALUES (FALSE POSITIVE) FROM THE INITIAL TESTING USING ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G). THE CUSTOMER BELIEVES THAT ALL OF THE INITIAL POSITIVE RESULTS ARE FALSE POSITIVE. THERE IS NO INDICATION THAT PATIENT TREATMENT WAS PRESCRIBED, DELAYED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10469235 ↗
• MalfunctionAug 3, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED DISCORDANT TOXOPLASMA IGG (TOXO G) RESULTS BETWEEN THE ADVIA CENTAUR XP AND AN ALTERNATE METHOD AND A PREVIOUS RESULT ON THE ADVIA CENTAUR XP. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXOPLASMA G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10359669 ↗
• MalfunctionJul 22, 2020False Positive Result; False Positive Result

  DISCORDANT (FALSE POSITIVE) RESULTS WERE OBTAINED ON FOUR SAMPLES FROM ONE PATIENT USING ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) LOT 261. THE CUSTOMER TESTED A SAMPLE ON (B)(6) 2020 AND OBTAINED A POSITIVE RESULT, WHICH WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF THE PHYSICIAN QUESTIONED THE RESULT. HISTORICAL TOXO G RESULTS FOR THIS PATIENT WERE NEGATIVE, SO ON (B)(6) 2020, THE CUSTOMER RETESTED THE SAMPLE AND ALSO THE TWO STORED SAMPLES THAT WERE USED TO OBTAIN THE NEGATIVE HISTORICAL RESULTS (LOT NUMBER USED FOR THE HISTORICAL RESULTS IS UNKNOWN). POSTIVE RESULTS WERE OBTAINED ON THE THREE SAMPLES USING ADVIA CENTAUR XPT TOXO G LOT 261 ON (B)(6) 2020. THE CUSTOMER ALSO TESTED THESE THREE SAMPLES USING AN ALTERNATE METHOD AND NEGATIVE RESULTS WERE OBTAINED. A NEW SAMPLE WAS DRAWN FROM THE SAME PATIENT AND TESTED USING ADVIA CENTAUR XPT TOXO G LOT 261. A POSITIVE RESULT WAS OBTAINED, BUT A NEGATIVE RESULT WAS OBTAINED ON AN ALTERNATE METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE ADVIA CENTAUR XPT TOXO G RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10311604 ↗