Elecsys TSH 08429324160Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613336157626), received between Aug 11, 2021 and Jul 24, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Low Test Results; Low Readings; Non Reproducible Results; Low Test Results; Low Readings; Non Reproducible Results

  1. DESCRIBE THE EVENT: THE INITIAL REPORTER COMPLAINED OF A DISCREPANT RESULT FOR 1 PATIENT TESTED FOR ELECSYS TSH V2 ON A COBAS E 411 ANALYZER (DISK SYSTEM). 2. PATIENT AGE RANGE: ASKU. 3. PATIENT WEIGHT RANGE: ASKU. 4. PATIENT SEX BREAKDOWN: ASKU. 5. PATIENT RACE BREAKDOWN: ASKU. 6. PATIENT ETHNICITY BREAKDOWN: ASKU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587232 ↗
• InjurySep 11, 2024High Test Results; Insufficient Device Problem Information; Non Reproducible Results; High Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF ANALYZER ALARMS AND A QUESTIONABLE TSH ELECSYS RESULT FROM THE COBAS 6000 E 601 ANALYZER. THE INITIAL RESULT FOR THE PATIENT WAS 6.78 UIU/ML. THE PATIENT REPORTEDLY HAD A TSH RESULT FROM A DIFFERENT SAMPLE FROM JUST A FEW DAYS EARLIER THAT WAS NORMAL. NO SPECIFIC DATA WAS PROVIDED. THE NURSE ALLEGEDLY ASKED THE LABORATORY TO SEND THE PATIENT SAMPLE FOR CONFIRMATION TESTING. THE RESULT FROM A REFERENCE LABORATORY USING AN UNKNOWN METHODOLOGY WAS REPORTED TO BE 2.54 UIU/ML. THE PATIENT ALLEGEDLY HAD ALREADY BEEN TAKING A SYNTHROID DOSE OF 75 MCG/DAY. REPORTEDLY, WHEN THE PHYSICIAN RECEIVED THE INITIAL TSH RESULT OF 6.78 UIU/ML, THE DOSAGE WAS CHANGED TO 100 MCG/DAY AND THE PATIENT WAS DISCHARGED. THE CUSTOMER ALLEGED THE PATIENT REPORTED DIARRHEA BUT IT WAS UNKNOWN IF THIS WAS RELATED TO THE INCREASE IN MEDICATION DOSAGE. THE CUSTOMER ALLEGEDLY WAS NOT AWARE OF ANY ADVERSE CONSEQUENCE OF THE INCREASE IN DOSAGE FOR THE PATIENT. REPORTEDLY, THE CUSTOMER COMMUNICATED THE CORRECTED RESULT TO THE PATIENT'S PHYSICIAN AND REPORTEDLY THE PATIENT'S MEDICATION DOSAGE WAS BROUGHT BACK DOWN TO THE PRIOR DOSAGE. THERE WAS NO ALLEGATION OF AN ADVERSE IMPACT TO THE FETUS.

  Patient problems: Diarrhea

  MAUDE report 20189935 ↗
• MalfunctionJan 31, 2024Low Test Results; Insufficient Device Problem Information; Low Test Results; Insufficient Device Problem Information

  THERE WAS AN ALLEGATION OF QUESTIONABLE TSH RESULTS FROM THE COBAS 8000 - COBAS E 602 MODULE. THE INITIAL RESULT WAS 0.2 MIU/ML AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN DID NOT AGREE WITH THE RESULT. A WEEK LATER, THE REPEAT RESULT FROM THE SAME SAMPLE WAS 1.87 MIU/ML. NEITHER RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614448 ↗
• MalfunctionMay 3, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH THE ELECSYS TSH ASSAY VER. 2 ON A COBAS E 411 ANALYZER (RACK SYSTEM). RESULTS WILL BE LOW AND THEN HIGHER WHEN REPEATED ON A SECOND ANALYZER. THE REPORTER PROVIDED AN EXAMPLE OF DATA FOR ONE PATIENT SAMPLE WITH DISCREPANT TSH RESULTS. THE REPORTER STATED THEY HAD BEEN HAVING ISSUES WITH TSH CALIBRATION AND CONTROLS. THE SAMPLE INITIALLY RESULTED IN A TSH VALUE OF < 0.005 MIU/ML WITH A DATA FLAG AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED SINCE PATIENT RESULTS WERE RECOVERING LOW. WHEN REPEATED ON THE SAME ANALYZER, THE TSH RESULT WAS 2.49 MIU/ML. THE REPEAT VALUE WAS DEEMED CORRECT. THE TSH REAGENT LOT NUMBER WAS 653309. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863228 ↗
• MalfunctionAug 11, 2021High Test Results; Insufficient Device Problem Information; High Test Results; Insufficient Device Problem Information

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR ONE PATIENT TESTED ON A COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4). PRIOR TO PATIENT TESTING, THE CUSTOMER'S TSH QC WAS ACCEPTABLE. THE PATIENT HAD TWO SAMPLES COLLECTED AT THE SAME TIME. ONE SAMPLE WAS TESTED ON THE COBAS 6000 E 601 MODULE AND THE OTHER SAMPLE WAS SENT TO A DIFFERENT LABORATORY AND WAS TESTED WITH AN UNKNOWN LABORATORY METHODOLOGY. THE PATIENT'S ELECSYS TSH RESULT WAS 7.06 UIU/ML. THE PATIENT'S TSH RESULT AT A DIFFERENT LABORATORY WAS 4.39 MIU/L. THE CUSTOMER WAS UNSURE WHICH RESULT WAS CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306087 ↗