VIDAS® TSH 30400-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026156886), received between Dec 17, 2020 and Dec 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX THAT THEY HAVE OBSERVED FALSELY LOW RESULTS FOR A PATIENT'S SAMPLE IN ASSOCIATION WITH THE VIDAS® TSH 60 TESTS (REF.# (B)(4), LOT 1007944800) COMPARED TO RESULTS OBTAINED BY AN EXTERNAL LABORATORY. THE CUSTOMER STATED THAT THEY HAD TESTED A PATIENT FOR TSH ON THEIR VIDAS, THE RESULTS WERE AS FOLLOWS: PATIENT 2: VIDAS RESULT = 0.29 (UNITS NOT REPORTED). REPEAT ANALYSIS WITH THE VIDAS TSH OBTAINED THE SAME RESULTS. THE SAMPLE WAS THEN SENT TO AN EXTERNAL LABORATORY FOR REFERENCE TESTING AS THE CUSTOMER INDICATED THAT THE VIDAS RESULTS DID NOT MATCH THE LAST TIME THE TSH WAS RAN FOR THE PATIENT. THE EXTERNAL LABORATORY RESULTS WERE AS FOLLOWS: PATIENT 2: LABCORP RESULT = 3.30 (UNITS NOT REPORTED). THE CUSTOMER WAS UNSURE WHICH TEST METHOD WAS USED BY THE EXTERNAL LABORATORY. THE CUSTOMER REPORTED THAT NO INCORRECT RESULTS WERE REPORTED TO THE TREATING PHYSICIAN, THERE WAS NO DELAY IN REPORTING RESULTS, AND THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11032502 ↗
• MalfunctionDec 17, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX THAT THEY HAVE OBSERVED FALSELY LOW RESULTS FOR A PATIENT'S SAMPLE IN ASSOCIATION WITH THE VIDAS® TSH 60 TESTS (REF.#: (B)(4), LOT #:1007944800) COMPARED TO RESULTS OBTAINED BY AN EXTERNAL LABORATORY. THE CUSTOMER STATED THAT THEY HAD TESTED A PATIENT TSH SAMPLE ON THEIR VIDAS, THE RESULTS WERE AS FOLLOWS: PATIENT 1: VIDAS RESULT = 0.08 (UNITS NOT REPORTED). REPEAT ANALYSIS WITH THE VIDAS TSH OBTAINED THE SAME RESULTS. THE SAMPLE WAS THEN SENT TO AN EXTERNAL LABORATORY FOR REFERENCE TESTING AS THE CUSTOMER INDICATED THAT THE VIDAS RESULTS DID NOT MATCH THE LAST TIME THE TSH WAS RAN FOR THE PATIENT. THE EXTERNAL LABORATORY RESULTS WERE AS FOLLOWS: PATIENT 1: LABCORP RESULT = 4.08 (UNITS NOT REPORTED). THE CUSTOMER WAS UNSURE, WHICH TEST METHOD WAS USED BY THE EXTERNAL LABORATORY. THE CUSTOMER REPORTED THAT NO INCORRECT RESULTS WERE REPORTED TO THE TREATING PHYSICIAN, THERE WAS NO DELAY IN REPORTING RESULTS, AND THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11032295 ↗