Elecsys Anti-TPO 07026935190Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04015630939626), received between Sep 14, 2018 and Feb 12, 2026 — classified as 31 malfunctions.

The most frequently reported specific device problem is “High Test Results” (25 reports).

1 other recall cover devices cleared under the same FDA submission (K051890); 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO RESULTS FOR MULTIPLE SAMPLES FROM ONE PATIENT WHILE USING THE COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER SUSPECTED INTERFERENCE BY BIOTIN TAKEN BY THE PATIENT. ON (B)(6) 2026, SAMPLE 1 RESULT WAS 18.1 U/L. THIS WAS THE BEGINNING OF BIOTIN SUPPLEMENTATION BY THE PATIENT. ON (B)(6) 2026, SAMPLE 2 RESULT WAS 87.4 IU/ML. THE REPEAT RESULT WAS 77.7 IU/ML. BIOTIN SUPPLEMENTATION BY THE PATIENT WAS STOPPED. ON (B)(6) 2026, THE RESULT USING A VIDAS ANALYZER WAS <0.8 IU/ML. ON 26-JAN-2026, SAMPLE 3 RESULT WAS 14.1 IU/ML. ON 26-JAN-2026, THE RESULT USING A VIDAS ANALYZER WAS <0.8 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320699 ↗
• MalfunctionNov 25, 2025High Test Results; No Apparent Adverse Event; Non Reproducible Results; High Test Results; No Apparent Adverse Event; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY HAVE HAD ONGOING ISSUES WITH QUALITY CONTROL ERRORS AND CONTROL RECOVERY FOR ELECSYS ANTI-TPO ON A COBAS E 801 ANALYTICAL UNIT. THE CUSTOMER TRIED RECALIBRATION BUT THIS DID NOT RESOLVE THE ISSUE. IN ADDITION TO A COMPLETE SYSTEM AND SIPPER FLOW PATH WASH, THE FOLLOWING PARTS WERE REPLACED: A SAMPLE PROBE, A LIQUID LEVEL DETECTION CIRCUIT BOARD, A SAMPLE SYRINGE UNIT, AND A SYSTEM REAGENT TUBE. THE ISSUE PERSISTED AFTER THESE ACTIONS. THE CUSTOMER PROVIDED DATA FOR TWO PATIENT SAMPLES WITH DISCREPANT ANTI-TPO RESULTS. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 37 IU/ML AND IT REPEATED WITH VALUES OF 9 IU/ML AND 9 IU/ML. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 36 IU/ML AND IT REPEATED WITH VALUES OF 13 IU/ML AND 9 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649808 ↗
• MalfunctionAug 15, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III, ELECSYS ANTI-TPO, AND ELECSYS ANTI-TG ON A COBAS E 801 ANALYTICAL UNIT AND A COBAS E 411 ANALYZER. THIS MEDWATCH WILL APPLY TO THE ANTI-TPO 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 ANTI-TG ASSAY. THE SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE E 801 ANALYZER: FT3 = 28.4 PMOL/L. ANTI-TPO = > 600 IU/ML. ANTI-TG = > 4000 IU/ML. THE SAMPLE RESULTED IN THE FOLLOWING VALUES WHEN TESTED ON THE E411 ANALYZER: FT3 = 8.7 PMOL/L. ANTI-TPO = 230.4 IU/ML. ANTI-TG = 200.1 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816189 ↗
• MalfunctionMar 20, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH ELECSYS ANTI-TPO ON A COBAS E 801 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. A TUBE OF THE FIRST SAMPLE INITIALLY RESULTED IN ANTI-TPO VALUES OF 37 IU/ML AND 9.43 IU/ML. THE PARENT TUBE OF THE SAMPLE WAS THEN REPEATED, RESULTING IN A VALUE OF 9.05 IU/ML. A TUBE OF THE SECOND SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 36 IU/ML. THE SAMPLE WAS THEN REPEATED, RESULTING IN A VALUE OF 12.4 IU/ML. A TUBE OF THE THIRD SAMPLE INITIALLY RESULTED IN AN ANTI-TPO VALUE OF 36.4 IU/ML. THE SAMPLE WAS THEN REPEATED, RESULTING IN A VALUE OF 12.7 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651820 ↗
• MalfunctionMar 7, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TPO RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO SB. ON (B)(6) 2025: THE INITIAL RESULT FROM THE ANALYZER WAS 16.40 U/ML. THE PATIENT'S PRIMARY CARE PHYSICIAN DISPUTED THE INITIAL RESULT. ON (B)(6) 2025: THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 17.80 U/ML. THE SECOND REPEAT RESULT FROM ANOTHER LABORATORY THAT USES A BECKMAN ANALYZER WAS 132.1 KU/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547035 ↗
• MalfunctionFeb 21, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ANTI-TPO RESULT FROM THE COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS > TEST 600 KIU/I, AND THE 1ST REPEAT RESULT WAS > TEST 600 KIU/I. THE 2ND REPEAT RESULT WITH A MANUAL DILUTION OF 1:5 WAS 14.3 KIU/I. THE 3RD REPEAT RESULT WITH A MANUAL DILUTION OF 1:5 WAS 13.5 KIU/I. THE 4TH REPEAT RESULT WITH A MANUAL DILUTION OF 1:1 WAS 117 KIU/I.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21431933 ↗
• MalfunctionFeb 4, 2025High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED THYROID RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A COMPETITOR METHOD. OF THE DATA PROVIDED, THE RESULTS FOR FT3, T4, T3, ANTI-TG AND ANTI-TPO WERE DISCREPANT. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. THIS MEDWATCH WILL COVER ANTI-TPO. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T4 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ANTI-TG RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21306959 ↗
• MalfunctionJan 14, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TPO RESULTS FROM ONE PATIENT SAMPLE TESTED ON THREE COBAS PURE E 402 ANALYTICAL UNITS AND TWO COBAS E411 ANALYZERS. THIS MEDWATCH IS FOR THE COBAS PURE E 402 ANALYTICAL UNIT ELECSYS ANTI-TPO REAGENT. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE COBAS E411 ANALYZER ELECSYS ANTI-TPO REAGENT. ON (B)(6) 2024: THE INITIAL RESULT FROM THE FIRST E 402 ANALYZER WAS 250 IU/ML OR 279.0 IU/ML. THE FIRST REPEAT RESULT FROM THE FIRST E 411 ANALYZER WAS 40.6 IU/ML OR 40 IU/ML. ON (B)(6) 2024: THE SECOND REPEAT RESULT FROM THE SECOND E 402 ANALYZER WAS 227 IU/ML. THE THIRD REPEAT RESULT FROM THE THIRD E 402 ANALYZER WAS 256 IU/ML. THE FOURTH REPEAT RESULT FROM THE SECOND E 411 ANALYZER WAS 48.86 WITH A DATA FLAG. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT DID NOT FIT THE CLINICAL PICTURE (THE PATIENT HAD PREVIOUS NORMAL RESULTS). THE REPORTER WAS UNSURE WHICH RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148860 ↗
• MalfunctionDec 5, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED HIGH RESULTS FOR 14 PATIENT SAMPLES TESTED FOR ELECSYS ANTI-TPO (ANTI- TPO) ON A COBAS E 801 ANALYTICAL UNIT. THE QUESTIONABLE RESULTS WERE OBTAINED ON (B)(6) 2024. ON THE EVENING OF (B)(6) 2024 QC RESULTS WERE HIGH OUTSIDE OF RANGE PROMPTING REPEAT TESTING ON (B)(6) 2024. OF THE DATA PROVIDED, THE RESULTS FOR 3 PATIENT SAMPLES WERE DISCREPANT. PATIENT 1 INITIAL RESULT WAS 50.1 IU/ML. THE REPEAT RESULT WAS 24.9 IU/ML. PATIENT 2 INITIAL RESULT WAS 53.6 IU/ML. THE REPEAT RESULT WAS 24.7 IU/ML. PATIENT 3 INITIAL RESULT WAS 39.6 IU/ML. THE REPEAT RESULT WAS 21 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857451 ↗
• MalfunctionSep 5, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO, ELECSYS ANTI-TG, ELECSYS ANTI-TSHR, AND ELECSYS TESTOSTERONE II RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH COVERS THE ALLEGED RESULTS FOR THE ELECSYS ANTI-TPO ASSAY. PLEASE REFER TO MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TG ASSAY RESULTS, MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TSHR ASSAY RESULTS, AND MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS TESTOSTERONE II ASSAY RESULTS. REFER TO THE HIGHLIGHTED SECTION OF ATTACHMENT (B)(6) FOR PATIENT RESULTS. THE SAMPLES WERE REPEATED DUE TO THE RESULTS NOT MATCHING THE CLINICAL STATUS OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146067 ↗
• MalfunctionJun 13, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO RESULTS FOR 2 PATIENT SERUM SAMPLES ON A COBAS E 801 MODULE. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL ANTI-TPO RESULT OF 42.7 IU/ML. AN ALIQUOT OF THE SAMPLE WAS REPEATED ON ANOTHER E801 ANALYZER AND THE RESULT WAS <9.00 IU/ML WITH FLAG. AN ALIQUOT SAMPLE WAS REPEATED ON THE ORIGINAL ANALYZER AND THE RESULT WAS 9.96 IU/ML THE ORIGINAL SAMPLE WAS ALSO REPEATED ON THE ORIGINAL ANALYZER AND THE RESULT WAS <9.00 IU/ML WITH FLAG. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL ANTI-TPO RESULT OF 42.0 IU/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 10.7 IU/ML AND 13.0 IU/ML. AN ALIQUOT OF THE SAMPLE WAS ALSO TESTED AND THE RESULT WAS 11.2 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528769 ↗
• MalfunctionApr 22, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS >600 IU/ML. THE REPEAT RESULT WITH A MANUAL 1:5 DILUTION WAS 23.9 (X5 =119.5) IU/ML. THE REPEAT RESULT UNDILUTED WAS >600 IU/ML. THE REPEAT RESULT WITH A MANUAL 1:5 DILUTION WAS 24 (X5 =120) IU/ML. TESTING OF THE SAMPLE BY ANOTHER METHOD (CMEIA) ON THE ARCHITECT ANALYZER, A RESULT WAS WITHIN THE NORMAL RANGE. NO SPECIFIC DATA WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19159485 ↗
• MalfunctionApr 4, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS ANTI-TPO (ANTI-TPO) ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 73.2 IU/ML. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF LESS THAN 9 IU/ML. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AS THESE MATCHED THE PATIENT¿S PREVIOUS ANTI-TPO RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041294 ↗
• MalfunctionFeb 26, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-TPO RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS >600 IU/ML. A MANUAL DILUTION (1:5) WAS PERFORMED AND THE RESULT WAS APPROXIMATELY 50 IU/ML. IT WAS REPORTED THAT A DILUTION WAS PERFORMED SEVERAL TIMES AND THE RESULT WAS ALWAYS APPROXIMATELY 50 IU/ML. A SECOND TEST TUBE OF THE SAME SAMPLE WAS TESTED. THE INITIAL RESULT WAS (1:1) >600 IU/ML. THE RESULT WITH A 1:5 DILUTION WAS 58.5 IU/ML. THE RESULT WITH A 1:2 DILUTION WAS 484 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779634 ↗
• MalfunctionDec 19, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE ANTI-TPO ELECSYS E2G RESULT FROM THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS >600 IU/ML WITH A DATA FLAG. THE REPEAT RESULT WITH A 1:5 DILUTION WAS 11.4 IU/ML. MULTIPLIED BY THE DILUTION FACTOR, THE RESULT WAS 57 IU/ML. THE SAMPLE WAS THEN TESTED USING CMEIA METHODOLOGY ON AN ARCHITECT ANALYZER AND THE RESULT WAS 2.69 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357246 ↗
• MalfunctionOct 12, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO AND ROCHE DIAGNOSTICS ELECSYS ANTI-TG RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THIS MDR IS FOR THE ANTI-TPO ASSAY. PLEASE REFER TO MDR WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TG ASSAY. THE REPORTER STATED THAT THE DIFFERENCES BETWEEN THE ANTI-TG AND ANTI-TPO RESULTS FROM THE ANALYZER AND THE MINDRAY INSTRUMENT WERE TOO LARGE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY BECAUSE THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE INITIAL ANTI-TPO RESULT FROM THE ANALYZER WAS 152.2 IU/ML. THE REPEAT RESULT FROM THE MINDRAY INSTRUMENT WAS 269.29 IU/ML. THE REFERENCE RANGES WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919239 ↗
• MalfunctionJun 7, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT FROM COBAS 8000 E 801 SERIAL NUMBER 2140-08 DUE TO INTERFERENCE. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER AND THE RESULTS WERE NORMAL AND IN LINE WITH THE CLINICAL EXPECTATIONS. THIS MEDWATCH IS FOR THE ANTI-TPO ASSAY. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17081303 ↗
• MalfunctionMay 9, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO RESULTS FOR 2 SAMPLES FROM 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT.ON (B)(6) 2023, THE INITIAL ANTI-TPO RESULT FOR SAMPLE 1 WAS 52.3 IU/ML.FOR SAMPLE 2, THE INITIAL ANTI-TPO RESULT WAS 12.3 IU/ML.ON (B)(6) 2023, BOTH SAMPLES WERE REPEATED TWICE.SAMPLE 1 HAD REPEAT RESULTS OF 9.0 IU/ML WITH FLAG AND 9.0 IU/ML WITH FLAG.SAMPLE 2 HAD REPEAT RESULTS OF 9.0 IU/ML WITH FLAG AND 9.0 IU/ML WITH FLAG.NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897287 ↗
• MalfunctionMay 1, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-TPO ON A COBAS 8000 SYSTEM SERIAL NUMBER (B)(6). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. AN ALIQUOT OF THE SAMPLE INITIALLY RESULTED IN A VALUE OF 52 IU/ML. THE ALIQUOT WAS REPEATED TWICE, RESULTING IN VALUES OF 9 IU/ML WITH A DATA FLAG AND 9 IU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845471 ↗
• MalfunctionApr 28, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TPO RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS 6000 E601 MODULE WITH SERIAL NUMBER 29S7-07 AND ANOTHER HOSPITAL LABORATORY'S E601 MODULE WITH AN UNKNOWN SERIAL NUMBER. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER STATED THAT THE PATIENT WAS HESITANT ABOUT THEIR CONDITION, WHICH PROMPTED RERUNS OF THE INITIAL PATIENT SAMPLE. THE PATIENT SAMPLE WAS ALIQUOTED INTO 3 PARTS AND WERE TESTED IN THE CUSTOMER'S E 601, AN AUTOBIO MACHINE, A SIEMENS MACHINE, AND ANOTHER E 601. THE REPORTER COMPLAINED THAT A NEGATIVE RESULT WAS OBTAINED FROM THE ELECSYS ANTI-TPO ASSAYS, WHEREAS POSITIVE RESULTS WERE OBTAINED FROM THE SIEMENS AND AUTOBIO ASSAYS. PLEASE REFER TO THE ATTACHMENT PT-81257 FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16833683 ↗
• MalfunctionApr 21, 2023High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 CORE UNIT. ON (B)(6) 2023, THE INITIAL ANTI-TPO RESULT FOR SAMPLE 1 FROM AN ALIQUOT OF THE ORIGINAL SAMPLE WAS 35 IU/ML. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 11 IU/ML. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 9 IU/ML WITH FLAG. ON (B)(6) 2023, THE INITIAL ANTI-TPO RESULT FOR SAMPLE 2 FROM AN ALIQUOT OF THE ORIGINAL SAMPLE WAS 66 IU/ML. THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 9 IU/ML WITH FLAG. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 9 IU/ML WITH FLAG. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER SERIAL NUMBER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791088 ↗
• MalfunctionApr 18, 2023High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TPO RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 WITH SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL RESULT USING AN ALIQUOTED SAMPLE WAS 37 IU/ML. THE FIRST REPEAT RESULT USING THE PRIMARY TUBE WAS 14 IU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT USING THE PRIMARY TUBE WAS 14 IU/ML WITH A DATA FLAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762668 ↗
• MalfunctionJan 12, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-TG AND ELECSYS ANTI-TPO RESULTS FROM SIX PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THIS MEDWATCH IS FOR THE ANTI-TPO ASSAY. PLEASE REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE ANTI-TG ASSAY. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS WERE COMPARED TO THREE OTHER NON-ROCHE ANALYZERS. THE REPORTER COMPLAINED THAT THE RESULTS FROM THE THREE NON-ROCHE ANALYZERS WERE ALL IN ACCORDANCE AND ONLY THE RESULTS FROM THE REPORTED ANALYZER WERE LOW. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16149916 ↗
• MalfunctionDec 5, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL ANTI-TPO RESULT WAS < 9 IU/ML. THE FIRST REPEAT RESULT WAS 68.1 IU/ML. THE SECOND REPEAT RESULT WAS < 9 IU/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT IS 63657901 AND THE EXPIRATION DATE IS 31-JAN-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920359 ↗
• 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-TPO ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TG ASSAY. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ANTI-TSHR ASSAY. 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 WERE "NORMAL". THE SECOND SAMPLE WAS TESTED ON (B)(6) 2022 ON TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734764 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051890. One submission often covers many models, so check the product and lot details in each record.

• Z-2981-2020 · Aug 20, 2020 · Terminated
  Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190