Elecsys Anti-TSHR 07026951190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630939954), received between Jul 24, 2018 and Sep 5, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “High Test Results” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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-TSHR 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 TESTOSTERONE II ASSAY RESULTS, AND MEDWATCH WITH A1 - PATIENT IDENTIFIER = (B)(6) FOR THE ALLEGED ELECSYS ANTI-TPO 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 20146069 ↗
• MalfunctionJul 26, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. DISCREPANT HIGH RESULTS WERE GENERATED BY TWO COBAS 8000 E 602 MODULES. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: ONE SAMPLE WITH DISCREPANT RESULTS FOR THE ELECSYS PTH STAT IMMUNOASSAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830164 ↗
• MalfunctionJul 26, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. DISCREPANT HIGH RESULTS WERE GENERATED BY A COBAS E 411 IMMUNOASSAY ANALYZER. THE EVENTS INVOLVED A TOTAL OF 2 PATIENTS WITH THE FOLLOWING: TWO SAMPLES WITH DISCREPANT RESULTS FOR THE ELECSYS PTH IMMUNOASSAY. ONE PATIENT'S GENDER WAS FEMALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830161 ↗
• MalfunctionJul 26, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. DISCREPANT LOW RESULTS WERE GENERATED BY TWO COBAS 8000 E 801 MODULES. THE EVENTS INVOLVED A TOTAL OF 1 PATIENT WITH THE FOLLOWING: ONE SAMPLE WITH DISCREPANT RESULTS FOR THE ELECSYS ANTI-TSHR IMMUNOASSAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8830154 ↗
• MalfunctionAug 10, 2018Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER QUESTIONED THYROID RESULTS FOR 1 PATIENT SAMPLE. NO RESULTS FROM THE CUSTOMER SITE WERE PROVIDED, BUT THE SAMPLE WAS PROVIDED FOR INVESTIGATION. THE PATIENT SAMPLE WAS TESTED FOR ELECSYS FT4 II ASSAY (FT4 II), ELECSYS TSH ASSAY (TSH), ELECSYS FT4 III (FT4 III), ELECSYS FT3 III (FT3 III) AND ELECSYS ANTI-TSHR IMMUNOASSAY ON A COBAS E 801 MODULE AND A COBAS E 411 IMMUNOASSAY ANALYZER USED AT THE INVESTIGATION SITE. BASED ON THE RESULTS GENERATED DURING THE TESTING AT THE INVESTIGATION SITE, THE RESULTS FOR FT3 III AND ANTI-TSHR WERE DISCREPANT. BASED ON THE RESULTS GENERATED FOR FT4 III, THE CUSTOMER SUSPECTS AN INTERFERENCE. REFER TO ATTACHED DATA FOR THE PATIENT RESULTS. THIS MEDWATCH WILL COVER ANTI-TSHR. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT3 III RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 III RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE CUSTOMER'S INSTRUMENT TYPE AND SERIAL NUMBER WERE NOT PROVIDED. THE E801 MODULE SERIAL NUMBER USED AT THE INVESTIGATION SITE WAS (B)(4). THE E411 MODULE SERIAL NUMBER USED AT TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7772891 ↗
• MalfunctionJul 24, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED QUESTIONABLE RESULTS WHEN TESTING 2 PATIENT SAMPLES WITH THE NEW ELECSYS ANTI-TSHR IMMUNOASSAY (ANTI-TSHR) REAGENT LOT NUMBER 322386 ON A COBAS 8000 E 801 MODULE (E801). OF THE TWO SAMPLES, ONE HAD AN ERRONEOUS ANTI-TSHR RESULT. IT WAS ASKED, BUT IT IS NOT KNOWN IF AN ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED WITH AN ANTI-TSHR VALUE OF 1.9 IU/L USING OLD LOT 283564. THE SAMPLE WAS REPEATED TWICE WITH NEW REAGENT LOT NUMBER 322386, RESULTING AS 1.32 IU/L AND 1.35 IU/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E801 ANALYZER WAS ASKED FOR, BUT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713447 ↗