Atellica IM Toxo G 10995699Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 00630414600123), received between Jan 31, 2020 and Aug 5, 2026 — classified as 92 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (82 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 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50140182 ↗
• MalfunctionFeb 10, 2026False Positive Result

  THE CUSTOMER REPORTS DISCORDANT TOXOPLASMA IGG (TOXO G) RESULTS FOR A PREGNANT PATIENT WITH REAGENT LOT 298. THE INITIAL ATELLICA IM TOXO G RESULT (SAMPLE # (B)(6) ON (B)(6) 2025) WAS REACTIVE (POSITIVE). THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAMPLE WAS SENT TO OTHER LABS FOR ALTERNATE METHOD TESTING. RESULTS FROM THE ALTERNATE METHODS WERE NON-REACTIVE (NEGATIVE). A SECOND SAMPLE FROM THE SAME PATIENT WAS DRAWN ON A DIFFERENT DATE (SAMPLE # (B)(6) ON (B)(6) 2026) AND RESULTED POSITIVE WITH ATELLICA IM TOXO G. THE SAMPLE WAS SENT TO OTHER LABS FOR ALTERNATE METHOD TESTING. RESULTS FROM THE ALTERNATE METHODS WERE NON-REACTIVE (NEGATIVE). THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301366 ↗
• MalfunctionFeb 10, 2026False Positive Result

  THE CUSTOMER REPORTS DISCORDANT TOXOPLASMA IGG (TOXO G) RESULTS FOR A PREGNANT PATIENT WITH REAGENT LOT 298. THE INITIAL ATELLICA IM TOXO G RESULT (SAMPLE # (B)(6) ON (B)(6) 2025) WAS REACTIVE (POSITIVE). THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAMPLE WAS SENT TO OTHER LABS FOR ALTERNATE METHOD TESTING. RESULTS FROM THE ALTERNATE METHODS WERE NON-REACTIVE (NEGATIVE). A SECOND SAMPLE FROM THE SAME PATIENT WAS DRAWN ON A DIFFERENT DATE (SAMPLE # (B)(6) ON (B)(6) 2026) AND RESULTED POSITIVE WITH ATELLICA IM TOXO G. THE SAMPLE WAS SENT TO OTHER LABS FOR ALTERNATE METHOD TESTING. RESULTS FROM THE ALTERNATE METHODS WERE NON-REACTIVE (NEGATIVE). THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301362 ↗
• MalfunctionFeb 10, 2026False Positive Result

  THE CUSTOMER OBTAINED REPEAT REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS FOR A PATIENT THAT WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TEST RESULTS. RESULTS WERE SENT TO THE PHYSICIAN AND THE PATIENT. THE CUSTOMER OBTAINED AN INITIAL POSITIVE ATELLICA IM TOXO G RESULT ON A SERUM SAMPLE (ID (B)(6) FROM THE PATIENT ON (B)(6) 2026. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LAB FOR ALTERNATE METHOD TESTING, WHICH RESULTED NON-REACTIVE (NEGATIVE). A NEW SERUM SAMPLE (B)(6) WAS DRAWN FROM THE SAME PATIENT ON THE NEXT DAY (B)(6) 2026) AND THE ATELLICA IM TOXO G RESULT WAS POSITIVE. THE CUSTOMER SENT THE SAMPLE TO TWO DIFFERENT LABS FOR ALTERNATE METHOD TESTING, WHICH RESULTED NEGATIVE. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301203 ↗
• MalfunctionFeb 10, 2026False Positive Result

  THE CUSTOMER OBTAINED REPEAT REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS FOR A PATIENT THAT WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TEST RESULTS. RESULTS WERE SENT TO THE PHYSICIAN AND THE PATIENT. THE CUSTOMER OBTAINED AN INITIAL POSITIVE ATELLICA IM TOXO G RESULT ON A SERUM SAMPLE (ID (B)(6)) FROM THE PATIENT ON (B)(6) 2026. THE CUSTOMER SENT THE SAMPLE TO ANOTHER LAB FOR ALTERNATE METHOD TESTING, WHICH RESULTED NON-REACTIVE (NEGATIVE). A NEW SERUM SAMPLE ((B)(6)) WAS DRAWN FROM THE SAME PATIENT ON THE NEXT DAY (B)(6) 2026 AND THE ATELLICA IM TOXO G RESULT WAS POSITIVE. THE CUSTOMER SENT THE SAMPLE TO TWO DIFFERENT LABS FOR ALTERNATE METHOD TESTING, WHICH RESULTED NEGATIVE. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301202 ↗
• MalfunctionJan 30, 2026False Positive Result

  THE CUSTOMER OBTAINED REPEAT REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS FOR A PATIENT THAT WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TEST RESULT AND THE PATIENT'S CLINICAL PRESENTATION AND AN HISTORICAL RESULT. THE CUSTOMER OBTAINED AN INITIAL POSITIVE ATELLICA IM TOXO G RESULT ON A SAMPLE (B)(6) FROM THE PATIENT ON (B)(6) 2025. RETESTING WAS PERFORMED AND ALSO RESULTED POSITIVE (N=2). A NEW SAMPLE (B)(6) WAS DRAWN FROM THE SAME PATIENT ON THE NEXT DAY (B)(6) 2025, AND THE RESULT WAS POSITIVE. THE CUSTOMER SENT ONE OF THE SAMPLES TO ANOTHER LAB FOR ALTERNATE METHOD TESTING, WHICH RESULTED NON-REACTIVE (NEGATIVE). THIS RESULT WAS ACCEPTED AS CORRECT AS IT WAS CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION AND HISTORICAL RESULT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225797 ↗
• MalfunctionJan 30, 2026False Positive Result

  THE CUSTOMER OBTAINED REPEAT REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS FOR A PATIENT THAT WERE DISCORDANT RELATIVE TO ALTERNATE METHOD TEST RESULT AND THE PATIENT'S CLINICAL PRESENTATION AND ANHISTORICAL RESULT. THE CUSTOMER OBTAINED AN INITIAL POSITIVE ATELLICA IM TOXO G RESULT ON A SAMPLE (ID (B)(6)) FROM THE PATIENT ON (B)(6) 2025. RETESTING WAS PERFORMED AND ALSO RESULTED POSITIVE (N=2). A NEW SAMPLE (ID (B)(6)) WAS DRAWN FROM THE SAME PATIENT ON THE NEXT DAY ((B)(6) 2025), AND THE RESULT WAS POSITIVE. THE CUSTOMER SENT ONE OF THE SAMPLES TO ANOTHER LAB FOR ALTERNATE METHOD TESTING, WHICH RESULTED NON-REACTIVE (NEGATIVE). THIS RESULT WAS ACCEPTED AS CORRECT AS IT WAS CONSISTENT WITH THE PATIENT'S CLINICAL PRESENTATION AND HISTORICAL RESULT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225785 ↗
• MalfunctionJan 27, 2026False Positive Result

  THE CUSTOMER OBTAINED REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) LOT 298 RESULTS ON 2 SAMPLES FROM ONE PATIENT WHO HAD BEEN HISTORICALLY NON-REACTIVE (NEGATIVE) AT THE ONSET OF HER PREGNANCY WITH AN ALTERNATE METHOD. ONE OF THESE SAMPLES WAS ALSO TESTED USING WESTERN BLOT AND RESULTED NEGATIVE, CONSISTENT WITH HISTORICAL RESULTS. TO INVESTIGATE, THE CUSTOMER TESTED THE HISTORICAL SAMPLES WITH ATELLICA IM TOXO G AND THE SAMPLES RESULTED POSITIVE. THE NEGATIVE RESULTS ARE CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192803 ↗
• MalfunctionJan 27, 2026False Positive Result

  THE CUSTOMER OBTAINED REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) LOT 298 RESULTS ON 2 SAMPLES FROM ONE PATIENT WHO HAD BEEN HISTORICALLY NON-REACTIVE (NEGATIVE) AT THE ONSET OF HER PREGNANCY WITH AN ALTERNATE METHOD. ONE OF THESE SAMPLES WAS ALSO TESTED USING WESTERN BLOT AND RESULTED NEGATIVE, CONSISTENT WITH HISTORICAL RESULTS. TO INVESTIGATE, THE CUSTOMER TESTED THE HISTORICAL SAMPLES WITH ATELLICA IM TOXO G AND THE SAMPLES RESULTED POSITIVE. THE NEGATIVE RESULTS ARE CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192799 ↗
• MalfunctionNov 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) LOT 297 RESULT ON 3 DIFFERENT SAMPLES FROM THE SAME PATIENT. THE SAMPLES WERE TESTED WITH AN ALTERNATE METHOD AND RESULTED NEGATIVE. IT IS UNKNOWN WHETHER THE INITIAL REACTIVE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496890 ↗
• MalfunctionNov 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) LOT 297 RESULT ON 3 DIFFERENT SAMPLES FROM THE SAME PATIENT. THE SAMPLES WERE TESTED WITH AN ALTERNATE METHOD AND RESULTED NEGATIVE. IT IS UNKNOWN WHETHER THE INITIAL REACTIVE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496522 ↗
• MalfunctionNov 7, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) LOT 297 RESULT ON 3 DIFFERENT SAMPLES FROM THE SAME PATIENT. THE SAMPLES WERE TESTED WITH AN ALTERNATE METHOD AND RESULTED NEGATIVE. IT IS UNKNOWN WHETHER THE INITIAL REACTIVE RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496385 ↗
• MalfunctionOct 24, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED AN INITIAL REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULT ON SAMPLE FROM A PREGNANT FEMALE PATIENT. THE SAMPLE WAS RETESTED AFTER CENTRIFUGING AND THE RESULT WAS POSITIVE. THE SAMPLE WAS TESTED ON TWO DIFFERENT ALTERNATE METHODS, AND THE RESULTS WERE NON-REACTIVE (NEGATIVE). THE INITIAL POSITIVE RESULTS WERE NOT REPORTED; THE NEGATIVE RESULTS WERE REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386580 ↗
• MalfunctionJul 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF A REACTIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING TOXO G KIT LOT 297. THE CUSTOMER HAS OBSERVED DISCORDANCE IN A SERIES OF TOXO G MEASUREMENTS FOR ONE PATIENT, WHERE REACTIVE TOXO G RESULTS CONFLICT WITH FOLLOW-UP TESTING BY WESTERN BLOT. A 31-YEAR-OLD FEMALE WAS MONITORED DURING PREGNANCY, AND PRODUCED THREE DISCORDANT RESULTS OVER A PERIOD OF SEVERAL WEEKS. THIS REPORT ADDRESSES THE THIRD OF THESE OBSERVATIONS (OTHER OBSERVATIONS REPORTED SEPARATELY). THE PATIENT PRODUCED REACTIVE TOXO G RESULTS IN EACH TEST, AND EACH TIME WESTERN BLOT DETERMINATION INDICATED NEGATIVE. THE NEGATIVE RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. 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 22383103 ↗
• MalfunctionJul 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING TOXO G KIT LOT 296. THE CUSTOMER HAS OBSERVED DISCORDANCE IN A SERIES OF TOXO G MEASUREMENTS FOR ONE PATIENT, WHERE REACTIVE TOXO G RESULTS CONFLICT WITH FOLLOW-UP TESTING BY WESTERN BLOT. A 31-YEAR-OLD FEMALE WAS MONITORED DURING PREGNANCY, AND PRODUCED THREE DISCORDANT RESULTS OVER A PERIOD OF SEVERAL WEEKS. THIS REPORT ADDRESSES THE SECOND OF THESE OBSERVATIONS (OTHERS REPORTED SEPARATELY). THE PATIENT PRODUCED REACTIVE TOXO G RESULTS IN EACH TEST, AND EACH TIME WESTERN BLOT DETERMINATION INDICATED NEGATIVE. THE NEGATIVE RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. 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 22382157 ↗
• MalfunctionJul 2, 2025False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING WHEN USING TOXO G KIT LOT 296. THE CUSTOMER HAS OBSERVED DISCORDANCE IN A SERIES OF TOXO G MEASUREMENTS FOR ONE PATIENT, WHERE REACTIVE TOXO G RESULTS CONFLICT WITH FOLLOW-UP TESTING BY WESTERN BLOT. A 31-YEAR-OLD FEMALE WAS MONITORED DURING PREGNANCY AND PRODUCED THREE DISCORDANT RESULTS OVER A PERIOD OF SEVERAL WEEKS. THIS REPORT ADDRESSES THE FIRST OF THESE DISCORDANT OBSERVATIONS (OTHERS REPORTED SEPARATELY). THE PATIENT PRODUCED REACTIVE TOXO G RESULTS IN EACH TEST, AND EACH TIME WESTERN BLOT DETERMINATION INDICATED NEGATIVE. THE NEGATIVE RESULTS WERE CONSIDERED CONSISTENT WITH THE PATIENT¿S CLINICAL CONDITION. 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 22382153 ↗
• MalfunctionJun 25, 2025False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULT ON A SAMPLE FROM A 32-YEAR-OLD PREGNANT FEMALE. THE RESULT WAS DISCORDANT RELATIVE TO A NON-REACTIVE (NEGATIVE) RESULT OBTAINED ON AN ALTERNATE TEST METHOD AT A REFERENCE LAB. THE INITIAL ATELLICA IM TOXO G REACTIVE RESULT WAS NOT REPORTED. THE ALTERNATE METHOD RESULT WAS REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330186 ↗
• MalfunctionSep 23, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) LOT 295 RESULT ON A SAMPLE FROM A PREGNANT PATIENT. THE POSITIVE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED BECAUSE THE PATIENT HAD BEEN PREVIOUSLY TESTED AT A NON-CUSTOMER WITH AN ALTERNATE TEST METHOD AND RESULTS WERE NON-REACTIVE (NEGATIVE). THE NEGATIVE RESULTS ARE BELIEVED TO BE CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280230 ↗
• MalfunctionJun 7, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) LOT 292 RESULT ON ONE PATIENT SAMPLE COMPARED TO 2 EQUIVOCAL RESULTS. THE SAME SAMPLE WAS RETESTED ON IMMULITE 2000 XPI AND THE RESULT WAS NON-REACTIVE (NEGATIVE). DUE TO THESE DISCORDANT RESULTS, THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY AND THE RESULT FROM A NON-SIEMENS TEST METHOD WAS NEGATIVE. THE REACTIVE RESULTS WERE NOT REPORTED. THE NON-REACTIVE RESULTS WERE REPORTED AS CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489234 ↗
• MalfunctionFeb 16, 2024False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF REACTIVE (POSITIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULTS WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE TOXO G KIT LOT 291 WAS IN USE. THE CUSTOMER INDICATES THAT REPRODUCIBLE REACTIVE ATELLICA IM TOXO G RESULTS WERE OBTAINED FOR A PREGNANT FEMALE PATIENT, AND THAT REPEAT TESTING USING AN ALTERNATE METHOD PRODUCED CONFLICTING NEGATIVE RESULTS. THE PATIENT HAS BEEN PREGNANT SINCE JULY 2023, AND HAD TESTED NEGATIVE FOR TOXO G AND TOXO M FROM JULY TO NOVEMBER OF 2023. ON (B)(6) 2023, REPEVAX (TETANUS-DIPHTHERIA-ACELLULAR PERTUSSIS (TDAP) VACCINE) WAS ADMINISTERED TO THE PATIENT. THE PATIENT WAS TESTED AGAIN IN DECEMBER 2023, AND A REACTIVE (POSITIVE) ATELLICA IM TOXO G RESULT WAS OBTAINED AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT, AND A SAMPLE WAS SENT TO AN EXTERNAL LAB FOR TESTING BY AN ALTERNATE METHOD. THE RESULTS FROM THE EXTERNAL LAB INDICATED NEGATIVE FOR BOTH TOXO G AND TOXO M. THE CUSTOMER REPORTS THAT THE SAME PATTERN OF RESULTS WAS OBSERVED IN JANUARY AND FEBRUARY FOR THE SAME PATIENT (DETAILS NOT PROVIDED). IT IS NOTED THAT A SAMPLE FROM THIS PATIENT WAS TESTED USING A SECOND ALTERNATE MET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18723056 ↗
• MalfunctionNov 22, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A POSITIVE (REACTIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) PATIENT SAMPLE RESULT THAT WAS CONSIDERED DISCORDANT COMPARED TO THE HISTORICALLY NEGATIVE (NON-REACTIVE) RESULTS OBTAINED FOR THIS PATIENT WHEN TESTED WITH ALTERNATE METHODS. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXO G RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190820 ↗
• MalfunctionNov 22, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED A POSITIVE (REACTIVE) ATELLICA IM TOXOPLASMA IGG (TOXO G) PATIENT SAMPLE RESULT THAT WAS CONSIDERED DISCORDANT COMPARED TO THE HISTORICALLY NEGATIVE (NON-REACTIVE) RESULTS OBTAINED FOR THIS PATIENT WHEN TESTED WITH ALTERNATE METHODS. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXO G RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190764 ↗
• MalfunctionOct 23, 2023False Positive Result; False Positive Result

  THE CUSTOMER REPORTS OBSERVATION OF A POSITIVE ATELLICA IM TOXOPLASMA IGG (TOXO G) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. AN INITIAL REACTIVE (POSITIVE) RESULT WAS OBTAINED FOR THE AFFECTED PATIENT AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT, AND A NEW TEST WAS PERFORMED USING A DIFFERENT ATELLICA IM ANALYZER. THE RE-TEST RESULT WAS NONREACTIVE (NEGATIVE), AND 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 17989299 ↗
• MalfunctionFeb 7, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED REPEAT POSITIVE (REACTIVE) TOXOPLASMA IGG (TOXO G) RESULTS FOR A PATIENT SAMPLE USING REAGENT LOT 280 ON AN ATELLICA IM 1600 ANALYZER. THE RESULTS WERE DISCORDANT COMPARED TO THE NEGATIVE (NON-REACTIVE) RESULT OBTAINED ON AN ALTERNATE METHOD. THE PATIENT ALSO HAD A HISTORICAL NEGATIVE RESULT. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315989 ↗
• MalfunctionFeb 7, 2023False Positive Result; False Positive Result

  THE CUSTOMER OBTAINED REPEAT POSITIVE (REACTIVE) TOXOPLASMA IGG (TOXO G) RESULTS FOR A PATIENT SAMPLE USING REAGENT LOT 280 ON AN ATELLICA IM 1600 ANALYZER. THE RESULTS WERE DISCORDANT COMPARED TO THE NEGATIVE (NON-REACTIVE) RESULT OBTAINED ON AN ALTERNATE METHOD. THE PATIENT ALSO HAD A HISTORICAL NEGATIVE RESULT. THERE ARE NO ALLEGATIONS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXO G RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315343 ↗