Elecsys Anti-TSHR 08496633190Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613336160329), received between Nov 22, 2021 and Jul 31, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “High Test Results” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K193313); 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026High Test Results; Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50097795 ↗
• MalfunctionMar 2, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER SUSPECTED AN INTERFERENCE. THE PATIENT'S RESULTS HAVE BEEN SIGNIFICANTLY ELEVATED AND DO NOT MATCH THE PATIENT'S CLINICAL PRESENTATION. ONE ANTI-TSHR RESULT OF 25.50 IU/L WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489371 ↗
• MalfunctionJan 21, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR 3 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. PATIENT 1: THE INITIAL RESULT WAS 1.24 IU/L. BETWEEN APPROXIMATELY (B)(6) 2025, THE REPEATED RESULT WAS 1.94 IU/L. PATIENT 2: THE INITIAL RESULT WAS 1.61 IU/L. BETWEEN APPROXIMATELY (B)(6) 2025, THE REPEATED RESULT WAS 2.32 IU/L. PATIENT 3: THE INITIAL RESULT WAS 1.46 IU/L. THE REPEATED RESULT WAS 2.04 IU/L. THE REPEATED RESULTS WERE OBTAINED ON A DIFFERENT MODULE (COBAS E602) USING A DIFFERENT ELECSYS ANTI-TSHR REAGENT LOT NUMBER (LOT 840177).

  Patient problems: Hyperthyroidism

  MAUDE report 24134137 ↗
• MalfunctionDec 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FOR QC MATERIAL AND PATIENT SAMPLES FROM THE COBAS E 801 ANALYTICAL UNIT. FOR ONE PATIENT, THE INITIAL RESULT WAS 4.7 IU/L. ON (B)(6) 2025, THE REPEAT RESULTS USING A NEW REAGENT CASSETTE OF THE SAME LOT NUMBER WERE 3.0-3.2 IU/L.

  Patient problems: Hyperthyroidism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876444 ↗
• MalfunctionDec 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT4 IV, ELECSYS FT3 III, AND ELECSYS ANTI-TSHR RESULTS FOR 1 PATIENT COBAS E 801 ANALYTICAL UNIT. SAMPLE 1: ON (B)(6) 2022, THE INITIAL FT4 RESULT WAS 1.72 NG/DL, AND THE REPEATED RESULT USING ANOTHER METHOD (CLIA ASSAY) IN ANOTHER LABORATORY WAS 1.03 NG/DL. THE INITIAL FT3 RESULT WAS 3.98 PG/ML, AND THE REPEATED RESULT USING ANOTHER METHOD (CLIA ASSAY) IN ANOTHER LABORATORY WAS 2.81 PG/ML. SAMPLE 2: ON (B)(6) 2025, THE ANTI-TSHR RESULT IS 2.9 IU/L. IT WAS ALLEGED THAT THE ANTI-TSHR RESULT WAS FALSELY ELEVATED, AND AN INTERFERENCE WITH THE ELECSYS ANTI-TSHR ASSAY WAS SUSPECTED. THIS MEDWATCH WILL APPLY TO THE ELECSYS ANTI-TSHR ASSAY. FOR SAMPLE 1 RESULTS OBTAINED ON (B)(6) 2022: PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FT4 IV ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FT3 III ASSAY.

  Patient problems: Hyperthyroidism

  MAUDE report 23863556 ↗
• MalfunctionOct 23, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 (B)(6) 2024) INITIAL RESULT WAS 40 IU/L WITH A DATA FLAG. THE AUTOMATIC REPEAT RESULT WAS 39.8 IU/L. THE SAMPLE WAS TESTED IN ANOTHER LAB, AND THE RESULT WAS 108 IU/L. SAMPLE 2 (B)(6) 2015) INITIAL RESULT WAS 40 IU/L WITH A DATA FLAG. THE RESULT WITH A 1:5 MANUAL DILUTION WAS 199.5 IU/L. THE RESULT WITH A 1:10 DILUTION WAS 312 IU/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. SAMPLE 3 (B)(6) 2025) INITIAL RESULT WAS 40 IU/L WITH A DATA FLAG. THE RESULT WITH A 1:3 MANUAL DILUTION WAS 120 IU/L. THE RESULT WITH A 1:5 DILUTION WAS 133 IU/L. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365547 ↗
• MalfunctionSep 4, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE THYROID RESULTS FOR ONE PATIENT FROM THE COBAS PRO SSU. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THIS MEDWATCH IS FOR THE ELECSYS ANTI-TSHR ASSAY. REFER TO THE MEDWATCHS WITH A1 PATIENT IDENTIFIERS (B)(6) AND (B)(6) FOR THE OTHER INVOLVED ASSAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962675 ↗
• MalfunctionMay 27, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III, ELECSYS FT4 IV, AND ELECSYS ANTI-TSHR ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE RESULTS MEASURED ON THE E 801 ANALYZER DID NOT COMPARE TO RESULTS MEASURED USING THE ABBOTT METHODS. THIS MEDWATCH WILL APPLY TO THE ANTI-TSHR ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY AND REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. THE RESULTS MEASURED ON THE E 801 ANALYZER ARE AS FOLLOWS: FT3 = 12.2 PMOL/L (REFERENCE RANGE = 3.1 - 6.8 PMOL/L),, FT4 = 59.9 PMOL/L (REFERENCE RANGE = 12 - 22 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = 14.00 IU/L (POSITIVE). THE RESULTS MEASURED USING THE ABBOTT METHOD ARE AS FOLLOWS: FT3 = 4.08 PMOL/L (REFERENCE RANGE = 3.45 - 5.5 PMOL/L), FT4 = 14.08 PMOL/L (REFERENCE RANGE = 11.0 - 17.7 PMOL/L), ANTI-TSHR TESTED ON (B)(6) 2025 = <0.7 IU/L (NEGATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088253 ↗
• MalfunctionAug 21, 2024Precipitate in Device or Device Ingredient; Precipitate in Device or Device Ingredient

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TSHR ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER STATED THEY STARTED NOTICING ISSUES WITH THE ELECSYS ANTI-TSHR PRE-TREATMENT REAGENT AS PRECIPITATES/CRYSTALS WERE OBSERVED IN THE WORKING SOLUTION EVEN AFTER 75 MINUTES OF ROTATION ON A ROLLER MIXER. THE ISSUE WAS ALSO NOTICED WITH A SECOND REAGENT LOT (LOT 801939), BUT THERE WAS NO IMPACT ON PATIENT DATA USING THIS LOT. DURING THE USE OF REAGENT LOT 76926902, THE REAGENT PACK HAD TO BE RECALIBRATED SINCE THE FIRST CONTROL LEVEL RECOVERED HIGH. PATIENT SAMPLES RUN BEFORE THE RE-CALIBRATION WERE REPEATED AFTER RE-CALIBRATING. ONE PATIENT SAMPLE HAD DISCREPANT ANTI-TSHR RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE USER REPEATED THE PATIENT SAMPLE SINCE APPROXIMATELY 70 % OF PATIENT SAMPLES USUALLY RESULT IN VALUES OF < 0.8 IU/L. THIS SAMPLE INITIALLY RESULTED IN AN ANTI-TSHR VALUE OF 3.4 IU/L. AFTER RE-CALIBRATION, THE SAMPLE RESULTED IN A VALUE OF 2.5 IU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20014958 ↗
• MalfunctionFeb 9, 2024Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR RESULTS FROM 20 PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT, COBAS 6000 E 601 MODULE, AND COBAS PURE E 402 ANALYTICAL UNIT. THIS MDR IS FOR THE ANTI-TSHR USED IN THE E 801 AND E 402 ANALYZERS. PLEASE REFER TO MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TSHR USED IN THE E 601 ANALYZER. THE REPORTER STATED THAT THEY CHANGED THEIR ANALYZER FROM A COBAS E601 TO A COBAS E 801 AND FOUND THAT THE ANTI-TSHR RESULTS TENDED TO BE LOWER ON THE E 801. THE REPORTER WAS NOT ABLE TO STATE WHICH RESULTS WERE DEEMED CORRECT. THE CLINICIAN QUESTIONED THE REASON FOR THE DISCREPANCY. THE REPORTER WAS ABLE TO PROVIDE SEVEN PATIENT SAMPLES WITH DISCREPANT RESULTS. PLEASE REFER TO THE ATTACHMENT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676218 ↗
• MalfunctionOct 21, 2022Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR IMMUNOASSAY RESULTS FROM 7 PATIENTS ON A COBAS E 801 MODULE. THE CUSTOMER REPORTED THAT THERE IS A RESULT DISCREPANCY BETWEEN 2 REAGENT LOTS. ON (B)(6) 2022, SAMPLE 1'S RESULT FROM LOT 566091 WAS 2.5 IU/L. THE RESULT FROM LOT 62838001 WAS 1.4 IU/L. THE SECOND RESULT FROM LOT 62838001 AFTER RE-CALIBRATION WAS 1.7 IU/L. ON (B)(6) 2022, SAMPLE 2'S RESULT FROM LOT 566091 WAS 2.6 IU/L. THE RESULT FROM LOT 62838001 WAS 1.5 IU/L. THE SECOND RESULT FROM LOT 62838001 AFTER RE-CALIBRATION WAS 1.6 IU/L. ON (B)(6) 2022, SAMPLE 3'S RESULT FROM LOT 566091 WAS 2.3 IU/L. THE RESULT FROM LOT 62838001 WAS 1.6 IU/L. ON (B)(6) 2022, SAMPLE 4'S RESULT FROM LOT 566091 WAS 2.2 IU/L. THE RESULT FROM LOT 62838001 WAS 1.5 IU/L. ON (B)(6) 2022, SAMPLE 5'S RESULT FROM LOT 566091 WAS 2.3 IU/L. THE RESULT FROM LOT 62838001 WAS 1.6 IU/L. ON (B)(6) 2022, SAMPLE 6'S RESULT FROM LOT 566091 WAS 2.5 IU/L. THE RESULT FROM LOT 62838001 WAS 1.8 IU/L. ON (B)(6) 2022, SAMPLE 18'S RESULT FROM LOT 566091 WAS 2.27 IU/L. THE FIRST RESULT FROM LOT 62838001 WAS 1.5 IU/L AND THE SECOND RESULT WAS 2.03 IU/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15654275 ↗
• MalfunctionSep 28, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-TSHR (ANTI-TSHR) ON A COBAS E801 MODULE. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION WHERE DISCREPANT RESULTS WERE IDENTIFIED BETWEEN THE CUSTOMER'S E801 MODULE, AN E801 MODULE USED AT THE INVESTIGATION SITE, AND AN OUTSOURCED YAMASA ANALYZER. THE RESULT FROM THE CUSTOMER¿S E801 MODULE WAS 5.6 IU/L. THE RESULT FROM THE E801 MODULE USED AT THE INVESTIGATION SITE WAS 5.88 IU/L. THE RESULT FROM THE YAMASA ANALYZER WAS < 1.0 IU/ML. THE CUSTOMER¿S E801 MODULE SERIAL NUMBER WAS NOT PROVIDED. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS 14D9-06.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15497228 ↗
• MalfunctionJun 17, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT TESTED WITH MULTIPLE THYROID ASSAYS ON A COBAS 8000 E 801 MODULE. ALL COMPLAINED THYROID RESULTS WERE ELEVATED WHEN MEASURED WITH THE ROCHE ASSAYS. THE SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. RESULTS FROM THE FOLLOWING ASSAYS ARE AFFECTED: FT3, THE ELECSYS FT4 III ASSAY, ANTI-TPO, ANTI-TG, AND ANTI-TSHR. THE SPECIFIC FT3, ANTI-TPO, ANTI-TG, AND ANTI-TSHR REAGENTS USED WERE REQUESTED, BUT NOT PROVIDED. THIS MEDWATCH WILL APPLY TO THE ANTI-TSHR ASSAY. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TPO ASSAY. REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TG ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE FIRST SAMPLE WAS TESTED ON (B)(6) 2022 AND HAD ELEVATED THYROID TEST RESULTS WHEN TESTED ON THE E 801 ANALYZER. WHEN TESTED AT ANOTHER SITE USING UNKNOWN METHODS, THE VALUES WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734809 ↗
• MalfunctionMar 4, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III, ELECSYS FT4 III ASSAY, ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO, ROCHE DIAGNOSTICS ELECSYS ANTI-TG, AND ELECSYS ANTI-TSHR RESULTS FOR ONE PATIENT TESTED ON TWO COBAS 8000 E 801 MODULES. THE SERIAL NUMBERS FOR THE E 801 MODULES WERE (B)(4). THE PATIENT'S ELECSYS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S PHYSICIAN QUESTIONED THE REPORTED RESULTS AS THE RESULTS DID NOT FIT THE PATIENT'S CLINICAL PICTURE. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO A DIFFERENT LABORATORY AND THE SAMPLE WAS TESTED ON AN UNKNOWN ROCHE ANALYZER "AND HAD SIMILAR RESULTS." THE PATIENT'S SAMPLE WAS SENT TO ANOTHER LABORATORY AND TESTED ON A "PRESUMABLY" SIEMENS ANALYZER. THE CUSTOMER CONFIRMED THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGES, BUT ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED. THIS MEDWATCH IS FOR THE ANTI-TSHR ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT3 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TPO ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TG ASSA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13671125 ↗
• MalfunctionJan 14, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TSHR RESULTS ON COBAS PRO SAMPLE SUPPLY UNIT, SERIAL NUMBER (B)(4). THIS MEDWATCH COVERS THE ALLEGED RESULTS FOR THE ELECSYS ANTI-TSHR ASSAY. PLEASE REFER TO MEDWATCH MDR-65386 FOR THE ALLEGED ELECSYS FT3 III ASSAY RESULTS. THE INITIAL RESULT WAS 3.6 IU/L. A DIFFERENT SAMPLE FROM THE SAME PATIENT WAS TESTED THE NEXT DAY AND THE RESULT WAS 2.3 IU/L. THE CUSTOMER REPEATED THE TEST WITH OTHER COMPETITOR METHODS. IT IS UNKNOWN IF THE RESULTS ARE FROM THE INITIAL SAMPLE OR THE SECOND SAMPLE. THE REPEATED RESULTS WERE 5.2 IU/L USING THE MALMÖ METHOD, <0.3 IU/L USING THE KRYPTOR METHOD, AND <1.5 IU/L USING THE PHADIA METHOD. THE RESULT OF <0.3 UI/L WAS CONSIDERED TO BE CORRECT. THE RESULTS WERE ASSESSED BY A DOCTOR. THE DATE OF EVENT IS UNCLEAR AS THE CUSTOMER STATES THEY PERFORMED TESTING ON (B)(6) 2021, BUT HAVE THE RESULTS LISTED FROM (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258976 ↗
• MalfunctionNov 22, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TSHR V2 RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE. THE E 801 MODULE SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL ELECSYS ANTI-TSHR RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER PERFORMED REPEAT TESTING WITH THE PATIENT'S SAMPLE WITH RRA METHODOLOGY. THE PATIENT'S ELECSYS ANTI-TSHR RESULT WAS 1.5 IU/L "NEGATIVE." THE PATIENT'S ANTI-TSHR RESULT WITH RRA METHODOLOGY WAS 2.3 IU/L "POSITIVE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12852440 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193313. One submission often covers many models, so check the product and lot details in each record.

• Z-1009-2026 · Nov 21, 2025 · Open, Classified
  The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is i