IMMULITE® 2000 Systems TXP Toxoplasma Quantitatve IgG 10381323Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00630414962238), received between Jul 31, 2017 and Apr 26, 2024 — classified as 49 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (23 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2024False Positive Result; False Positive Result

  A FALSE POSITIVE TOXOPLASMA QUANTITATIVE IGG RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT AND NEGATIVE. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXOPLASMA QUANTITATIVE IGG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194127 ↗
• MalfunctionApr 26, 2024False Positive Result; False Positive Result

  A FALSE POSITIVE TOXOPLASMA QUANTITATIVE IGG RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. THE REPEAT RESULT WAS LOWER THAN THE ERRONEOUS RESULT AND NEGATIVE. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXOPLASMA QUANTITATIVE IGG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19194109 ↗
• MalfunctionMar 18, 2024High Test Results; High Test Results

  A FALSELY ELEVATED (REACTIVE) TOXOPLASMA QUANTITATIVE IGG RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). FOR TROUBLESHOOTING, THE SAMPLE WAS REPEATED IN MULTIPLE REPLICATES ON THE SAME INSTRUMENT ON TWO ADDITIONAL DATES. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULT. MOST REPEAT RESULTS WERE NONREACTIVE, ONE REPEAT RESULT WAS INDETERMINATE, AND TWO REPEAT RESULTS WERE REACTIVE. THE SAMPLE WAS ALSO TESTED WITH THE TOXOPLASMA IGM ASSAY ON THE IMMULITE 2000 XPI INSTRUMENT AND WAS NONREACTIVE FOR TOXOPLASMA IGM. HISTORICAL RESULTS FROM (B)(6) 2023 WERE NONREACTIVE FOR TOXOPLASMA IGG AND TOXOPLASMA IGM. ALTERNATE LABORATORY RESULTS FROM FEBRUARY 2024 (INSTRUMENT UNKNOWN) WERE NONREACTIVE FOR TOXOPLASMA IGG AND TOXOPLASMA IGM. THE NONREACTIVE TOXOPLASMA IGG RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED TOXOPLASMA QUANTITATIVE IGG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924591 ↗
• MalfunctionFeb 28, 2024Non Reproducible Results; Non Reproducible Results

  IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED IN MULTIPLE REPLICATES ON BOTH THE INITIAL IMMULITE 2000 XPI INSTRUMENT AND AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT REPLICATES ON BOTH INSTRUMENTS REMAINED IMPRECISE WITH SOME REPLICATES RESULTING REACTIVE AND SOME REPLICATES RESULTING AS NONREACTIVE. PER THE CUSTOMER, THE TRUE RESULTS REMAIN "UNCLEAR". THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800563 ↗
• MalfunctionFeb 28, 2024Non Reproducible Results; Non Reproducible Results

  IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAMPLE WAS REPEATED IN MULTIPLE REPLICATES ON THE SAME IMMULITE 2000 XPI ON THE DATE OF INITIAL TESTING AND WAS REPEATED ON THE SAME IMMULITE 2000 XPI ON A DIFFERENT DATE. THE REPEAT REPLICATES FROM BOTH EVENT DATES REMAINED IMPRECISE WITH SOME REPLICATES RESULTING REACTIVE AND SOME REPLICATES RESULTING AS NONREACTIVE. PER THE CUSTOMER, THE TRUE RESULT REMAINS "UNCLEAR". THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800490 ↗
• MalfunctionFeb 28, 2024Non Reproducible Results; Non Reproducible Results

  IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAMPLE WAS REPEATED IN MULTIPLE REPLICATES ON THE SAME IMMULITE 2000 XPI ON THE DATE OF INITIAL TESTING AND WAS REPEATED ON THE SAME IMMULITE 2000 XPI ON A DIFFERENT DATE. THE REPEAT REPLICATES FROM BOTH EVENT DATES REMAINED IMPRECISE WITH SOME REPLICATES RESULTING REACTIVE AND SOME REPLICATES RESULTING AS NONREACTIVE. PER THE CUSTOMER, THE TRUE RESULT REMAINS "UNCLEAR". THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800305 ↗
• MalfunctionFeb 28, 2024Non Reproducible Results; Non Reproducible Results

  IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT. THE INITIAL RESULTS WERE REPORTED TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED IN MULTIPLE REPLICATES ON BOTH THE INITIAL IMMULITE 2000 XPI INSTRUMENT AND AN ALTERNATE IMMULITE 2000 XPI INSTRUMENT. THE REPEAT REPLICATES ON BOTH INSTRUMENTS REMAINED IMPRECISE WITH SOME REPLICATES RESULTING REACTIVE AND SOME REPLICATES RESULTING AS NONREACTIVE. PER THE CUSTOMER, THE TRUE RESULTS REMAIN "UNCLEAR". THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE IMPRECISE TOXOPLASMA QUANTITATIVE IGG RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796762 ↗
• MalfunctionDec 5, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A DISCORDANT FALSELY REACTIVE PATIENT RESULT OF 10.2 IU/ML WHEN USING IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) WHEN USING KIT LOT 517. THE CUSTOMER EXPECTED A NON REACTIVE RESULT. THE SAMPLE WAS REPEATED WITH NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) AND THE RESULT WAS 11.3 IU/ML WHICH WAS STILL REACTIVE, BUT WITH HETEROPHILIC BLOCKING TUBES (HBT) THE RESULT WAS 6.5 IU/ML WHICH WAS INDETERMINATE. THE SAME SAMPLE WAS THEN RUN ON AN ALTERNATE METHOD AND THE RESULT WAS 0.7 IU/ML WHICH WAS NON REACTIVE AS EXPECTED. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920585 ↗
• MalfunctionOct 25, 2022False Positive Result; False Positive Result

  WHEN USING THE IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) ASSAY, THE CUSTOMER OBSERVED A REACTIVE (POSITIVE) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO PATIENT HISTORY AND ALTERNATE-METHOD TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666593 ↗
• MalfunctionSep 23, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED DISCORDANT IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) TEST RESULTS ON THREE PATIENT SAMPLES IN COMPARISON TO AN ALTERNATE METHOD. IMMULITE 2000 XPI TXP RESULTS FOR THESE SAMPLES WERE NOT REPORTED TO THE PHYSICIAN, RESULTS FROM THE ALTERNATE METHOD WERE REPORTED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES OCCURRED DUE TO THE DISCORDANT IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470004 ↗
• MalfunctionJul 13, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A REACTIVE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) RESULT FOR A PATIENT SAMPLE THAT WAS NONREACTIVE ON AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REACTIVE TXP RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007063 ↗
• MalfunctionJul 13, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A REACTIVE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) RESULT FOR A PATIENT SAMPLE. THE SAMPLE WAS REACTIVE UPON REPEAT TESTING ON THE SAME SYSTEM BUT NONREACTIVE ON AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REACTIVE TXP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006950 ↗
• MalfunctionJul 13, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A REACTIVE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) RESULT FOR A PATIENT SAMPLE. THE SAMPLE WAS REACTIVE UPON REPEAT TESTING ON THE SAME SYSTEM BUT NONREACTIVE ON AN ALTERNATE METHOD. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REACTIVE TXP RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006865 ↗
• MalfunctionMay 27, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED REACTIVE (POSITIVE) RESULTS FOR THE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) USING LOT 515 FOR A PATIENT SAMPLE THAT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE NONREACTIVE (NEGATIVE) PREVIOUS RESULT. THE VALUE FOR THE RESULTS WAS GREATER THAN 250 IU/ML. THE CUSTOMER COLLECTED A NEW SAMPLE FOR TESTING AND THE RESULT WAS NONREACTIVE (NEGATIVE). THE INITIAL SAMPLE FROM (B)(6) 2022 WAS THAWED AND RETESTED. THE RESULTS WERE NONREACTIVE (NEGATIVE). THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXOPLASMA QUANTITATIVE IGG (TXP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14521666 ↗
• MalfunctionMay 12, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A DISCORDANT POSITIVE RESULT ON THE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) USING LOT 519 FOR A PATIENT SAMPLE WHEN COMPARED TO THE NEGATIVE RESULTS FROM THE ADVIA CENTAUR SYSTEM AND AN ALTERNATE METHOD. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POSITIVE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14375875 ↗
• MalfunctionMay 12, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A DISCORDANT POSITIVE RESULT ON THE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) USING LOT 519 FOR A PATIENT SAMPLE WHEN COMPARED TO THE NEGATIVE RESULTS FROM THE ADVIA CENTAUR SYSTEM AND AN ALTERNATE METHOD. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POSITIVE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14375866 ↗
• MalfunctionMay 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED POSITIVE RESULTS WITH IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) COMPARED TO HISTORICAL RESULTS AND RESULTS GENERATED ON THE ATELLICA IM AT ANOTHER SITE. THE SAMPLES WERE RE-CENTRIFUGED AND RETESTED ON THE IMMULITE 2000 TXP ASSAY AND WERE STILL POSITIVE. IT IS UNKNOWN WHETHER THE POSITIVE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE TOXOPLASMA QUANTITATIVE IGG POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342848 ↗
• MalfunctionMay 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED POSITIVE RESULTS WITH IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) COMPARED TO HISTORICAL RESULTS AND RESULTS GENERATED ON THE ATELLICA IM AT ANOTHER SITE. THE SAMPLES WERE RE-CENTRIFUGED AND RETESTED ON THE IMMULITE 2000 TXP ASSAY AND WERE STILL POSITIVE. IT IS UNKNOWN WHETHER THE POSITIVE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE TOXOPLASMA QUANTITATIVE IGG POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342823 ↗
• MalfunctionMay 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED POSITIVE RESULTS WITH IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) COMPARED TO HISTORICAL RESULTS AND RESULTS GENERATED ON THE ATELLICA IM AT ANOTHER SITE. THE SAMPLES WERE RE-CENTRIFUGED AND RETESTED ON THE IMMULITE 2000 TXP ASSAY AND WERE STILL POSITIVE. IT IS UNKNOWN WHETHER THE POSITIVE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE TOXOPLASMA QUANTITATIVE IGG POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342811 ↗
• MalfunctionMay 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED POSITIVE RESULTS WITH IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) COMPARED TO HISTORICAL RESULTS AND RESULTS GENERATED ON THE ATELLICA IM AT ANOTHER SITE. THE SAMPLES WERE RE-CENTRIFUGED AND RETESTED ON THE IMMULITE 2000 TXP ASSAY AND WERE STILL POSITIVE. IT IS UNKNOWN WHETHER THE POSITIVE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE TOXOPLASMA QUANTITATIVE IGG POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342810 ↗
• MalfunctionMay 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED POSITIVE RESULTS WITH IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) COMPARED TO HISTORICAL RESULTS AND RESULTS GENERATED ON THE ATELLICA IM AT ANOTHER SITE. THE SAMPLE WAS RE-CENTRIFUGED AND RETESTED ON THE IMMULITE 2000 TXP ASSAY AND WAS STILL POSITIVE. IT IS UNKNOWN WHETHER THE POSITIVE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE TOXOPLASMA QUANTITATIVE IGG POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342807 ↗
• MalfunctionMay 9, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED POSITIVE RESULTS WITH IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) COMPARED TO HISTORICAL RESULTS AND RESULTS GENERATED ON THE ATELLICA IM AT ANOTHER SITE. THE SAMPLE WAS RE-CENTRIFUGED AND RETESTED ON THE IMMULITE 2000 TXP ASSAY AND WAS STILL POSITIVE. IT IS UNKNOWN WHETHER THE POSITIVE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT IMMULITE TOXOPLASMA QUANTITATIVE IGG POSITIVE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342806 ↗
• MalfunctionAug 6, 2021False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A DISCORDANT, REACTIVE INITIAL RESULT ON A PATIENT SAMPLE USING THE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) ASSAY. THE SAMPLE WAS REPEATED IN DUPLICATE, RESULTING REACTIVE USING THE SAME REAGENT LOT AND INSTRUMENT. THE REACTIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE PATIENT HAD PREVIOUSLY TESTED NONREACTIVE ON THE IMMULITE 2000 XPI TOXOPLASMA QUANTITATIVE IGG (TXP) ASSAY THE PRIOR MONTH. THE CUSTOMER SENT THE PATIENT SAMPLES TO A REFERENCE LABORATORY FOR FURTHER TESTING ON ALTERNATE TOXOPLASMA IGG AND TOXOPLASMA IGM TEST METHODS, ALL RESULTING NONREACTIVE. THE REFERENCE LABORATORY TOXOPLASMA IGG NONREACTIVE RESULTS WERE CONSIDERED CORRECT. THERE ARE NO KNOWN REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXOPLASMA QUANTITATIVE IGG (TXP) RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291527 ↗
• MalfunctionFeb 11, 2021False Positive Result; False Positive Result

  WHEN USING THE IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) ASSAY, THE CUSTOMER OBSERVED REACTIVE (POSITIVE) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO PATIENT HISTORY AND ALTERNATE-METHOD TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317838 ↗
• MalfunctionFeb 11, 2021False Positive Result; False Positive Result

  WHEN USING THE IMMULITE 2000 TOXOPLASMA QUANTITATIVE IGG (TXP) ASSAY, THE CUSTOMER OBSERVED REACTIVE (POSITIVE) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317810 ↗