IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab) 10381659Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00630414962108), received between Jan 29, 2018 and Jan 29, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K991094); they may or may not involve this specific model.

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.

Recalls naming this device

1. Apr 23, 2024Class IIOpen, Classified

   The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of IMMULITE 2000 Anti-TG Ab.

   Z-1886-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Low Test Results

  THE CUSTOMER CONTACTED SIEMENS AND INDICATED THAT A FALSE LOW ANTI-THYROGLOBULIN (ATG) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN IMMULITE 2000 XPI SYSTEM USING IMMULITE 2000 ATG REAGENT. THE FALSE LOW RESULT WAS REPORTED AND QUESTIONED. THE FOLLOWING DAY, THE SAMPLE WAS RUN FOR ATG IN ANOTHER LABORATORY USING A NON-SIEMENS METHOD AND THE RESULT RECOVERED HIGHER. THE HIGHER 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 LOW ATG RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24206836 ↗
• MalfunctionFeb 4, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI ON A SINGLE PATIENT. THREE INITIAL TESTING USING SIEMENS ADVIA CENTAUR XP WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). A LATER TEST WITH IMMULITE 2000 XPI WAS CONSIDERED DISCORDANT BUT WAS REPORTED TO THE PHYSICIAN(S) THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9667670 ↗
• MalfunctionFeb 4, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI ON A SINGLE PATIENT. THREE INITIAL TESTING USING SIEMENS ADVIA CENTAUR XP WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). A LATER TEST WITH IMMULITE 2000 XPI WAS CONSIDERED DISCORDANT BUT WAS REPORTED TO THE PHYSICIAN(S) THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9667669 ↗
• MalfunctionFeb 4, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI ON A SINGLE PATIENT. THREE INITIAL TESTING USING SIEMENS ADVIA CENTAUR XP WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). TWO ADDITIONAL TESTING USING AN ALTERNATE NON-SIEMENS METHOD WERE ALSO CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). A LATER TEST USING IMMULITE 2000 XPI WAS CONSIDERED DISCORDANT BUT WAS REPORTED TO THE PHYSICIAN(S). ANOTHER TEST USING SIEMENS ATELLICA IM WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9667659 ↗
• MalfunctionFeb 4, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI ON A SINGLE PATIENT. THREE INITIAL TESTING USING SIEMENS ADVIA CENTAUR XP WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). A LATER TEST WITH IMMULITE 2000 XPI WAS CONSIDERED DISCORDANT BUT WAS REPORTED TO THE PHYSICIAN(S) THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9667648 ↗
• MalfunctionFeb 4, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI ON A SINGLE PATIENT. THREE INITIAL TESTING USING SIEMENS ADVIA CENTAUR XP WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). A LATER TEST WITH IMMULITE 2000 XPI WAS CONSIDERED DISCORDANT BUT WAS REPORTED TO THE PHYSICIAN(S) THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9667484 ↗
• MalfunctionOct 30, 2019Low Test Results; Low Test Results

  THREE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS USING SIEMENS ATELLICA IM WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9257612 ↗
• MalfunctionSep 27, 2019Low Test Results; Low Test Results

  THREE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULTS WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS USING SIEMENS ATELLICA IM WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131712 ↗
• MalfunctionSep 27, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WAS OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULT USING SIEMENS ATELLICA IM WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131711 ↗
• MalfunctionSep 27, 2019Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS USING SIEMENS ATELLICA IM WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) AND WERE CONSIDERED DISCORDANT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131708 ↗
• MalfunctionSep 27, 2019Low Test Results; Low Test Results

  TWO DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULT WERE OBTAINED USING IMMULITE 2000 XPI. THE INITIAL RESULTS USING SIEMENS ATELLICA IM WERE CONSIDERED CORRECT AND WERE REPORTED TO THE PHYSICIAN(S). THE REPEAT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S) AND WERE CONSIDERED DISCORDANT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9131704 ↗
• MalfunctionJul 5, 2019Low Test Results; Low Test Results

  FOUR DISCORDANT, FALSELY DEPRESSED ANTI-THYROGLOBULIN ANTIBODY (ATG) RESULTS ON A SINGLE PATIENT WERE OBTAINED USING IMMULITE 2000 XPI ON THE SAME DAY. THE INITIAL RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN(S). THREE REPEAT RESULTS USING THE SAME IMMULITE 2000 XPI WERE CONSIDERED DISCORDANT. THREE REPEAT RESULTS USING AN ALTERNATE NON-SIEMENS METHOD WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). TWO ADDITIONAL REPEAT RESULTS USING SIEMENS ATELLICA SOLUTIONS WERE ALSO CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ATG RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8765362 ↗
• MalfunctionMar 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT, FALSELY LOW AUTOANTIBODIES TO THYROGLOBULIN (ANTI-TG AB) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 673. THE RESULTS FROM IMMULITE 2000 XPI INSTRUMENT WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ADVIA CENTAUR XPT INSTRUMENT, RESULTING HIGHER. THE RESULTS FROM THE ADVIA CENTAUR XPT INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW ANTI-TG AB RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371322 ↗
• MalfunctionMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY LOW RESULT WAS OBTAINED FOR AUTOANTIBODIES TO THYROGLOBULIN (ANTI-TG AB) ASSAY ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 675. THE RESULT FROM THE IMMULITE 2000 XPI INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED ON AN ALTERNATE PLATFORM, RESULTING HIGHER. IT IS UNKNOWN IF THE RESULT FROM THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW ANTI-TG AB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7310279 ↗
• MalfunctionMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISCORDANT, FALSELY LOW RESULT WAS OBTAINED FOR AUTOANTIBODIES TO THYROGLOBULIN (ANTI-TG AB) ASSAY ON ONE PATIENT SAMPLE ON AN IMMULITE 2000 XPI INSTRUMENT, WHILE USING KIT LOT 675. THE RESULT FROM THE IMMULITE 2000 XPI INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED ON AN ALTERNATE PLATFORM, RESULTING HIGHER. IT IS UNKNOWN IF THE RESULT FROM THE ALTERNATE PLATFORM WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY LOW ANTI-TG AB RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7310277 ↗
• MalfunctionFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER CALLED SIEMENS TO INFORM THAT AN ANTI-THYROGLOBULIN (ANTI-TG) PATIENT RESULT OBTAINED ON AN ALTERNATE PLATFORM WAS ABNORMAL HIGH FOR ANTI TG AND USED TO COMPARE AGAINST THE IMMULITE 2000 XPI ANTI-TG RESULT. THE CUSTOMER STATED THAT THE INITIAL PATIENT TEST RESULT OBTAINED ON THE IMMULITE 2000 XPI SYSTEM IS IN A NORMAL RANGE AND REPORTED TO THE PHYSICIAN. THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN AND THE SAME PATIENT SAMPLE WAS USED FOR REPEAT TESTING ON AN ALTERNATE IMMULITE 2000 XPI SYSTEM. THE CUSTOMER INFORMED THAT THE REPEATED TEST RESULT WAS ALSO IN A NORMAL RANGE AND NOT AN EXPECTED RESULT. THE CUSTOMER STATED THAT THE INITIAL RESULT OBTAINED FROM THE ALTERNATE PLATFORM IS CORRECT DUE TO THE CLINICAL CONDITION OF THE PATIENT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE ANTI-TG DISCORDANT PATIENT RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287138 ↗
• MalfunctionJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISCORDANT AUTOANTIBODIES TO THYROGLOBULIN (ANTI-TG AB) RESULTS WERE OBTAINED ON PATIENT SAMPLES WHEN COMPARING THE RESULTS BETWEEN IMMULITE 2000 XPI AND ADVIA CENTAUR XPT INSTRUMENTS. THE RESULTS FROM IMMULITE 2000 XPI INSTRUMENT WERE NOT REPORTED TO THE PHYSICIAN(S). THE RESULTS FROM THE ADVIA CENTAUR XPT INSTRUMENT WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ANTI-TG AB RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7226121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991094. One submission often covers many models, so check the product and lot details in each record.

• Z-1887-2024 · Apr 23, 2024 · Open, Classified
  IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.