Elecsys AntiTSHR Immunoassay 4388780160Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630938896), received between Jul 20, 2018 and Jul 20, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2018High Test Results; High Test Results

  THE CUSTOMER QUESTIONED RESULTS FOR 1 PATIENT TESTED FOR ELECSYS FT4 II (FT4 II), TSH, ANTI-TPO AND ANTI-TSHR ON A COBAS E 801 MODULE. REFER TO THE ASSOCIATED MEDWATCHES WITH THE FOLLOWING PATIENT IDENTIFIERS: (B)(4). BETWEEN (B)(6) 2017 AND (B)(6) 2018 THE PATIENT HAD INCREASED FT4 II RESULTS (29-52 PMOL/L) AND LOW TSH RESULTS (0.04 - 0.17 MIE/L) IN 14 DIFFERENT SAMPLES FROM THE PATIENT WHEN TESTED ON THE E801 MODULE. ANTI-TPO RESULTS WERE > 600 IE/ML IN 6 DIFFERENT SAMPLES FROM THE PATIENT WHEN TESTED ON THE E801 MODULE. THE PATIENT PREVIOUSLY HAD NEGATIVE ANTI-TSHR RESULTS IN 2 DIFFERENT SAMPLES WHEN TESTED BY THE BRAHMS METHOD, HOWEVER, WHEN THE CUSTOMER CHANGED TO THE ROCHE METHOD IN (B)(6) 2017, THE PATIENT HAD POSITIVE ANTI-TSHR IN 7 DIFFERENT SAMPLES WHEN TESTED ON THE E801 MODULE. THE ACTUAL RESULTS WERE NOT PROVIDED. THE ROCHE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PATIENT WAS DIAGNOSED WITH HYPERTHYROIDISM AND TREATMENT WAS STARTED WITH NEO-MERCAZOLE IN (B)(6) 2017. THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE PATIENT SAMPLE AS THE PATIENT'S CLINICAL SYMPTOMS DO NOT AGREE WITH THE RESULTS. THE CUSTOMER SENT 3 PATIENT SAMPLES OBTAINED IN (B)(6) 2018 AND

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7706292 ↗