VIDAS® CMV IgG 30204-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03573026156831), received between Feb 8, 2019 and Feb 19, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K920661); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A (B)(6) RESULT FOR A (B)(6) SURVEY 2018 (B)(6) SAMPLE (B)(6) IN ASSOCIATION WITH THE VIDAS® CMV IGG ASSAY. THE CUSTOMER TWICE OBTAINED A (B)(6) RESULT, WHEN THE EXPECTED RESULT WAS (B)(6). THERE WAS NO PATIENT INVOLVEMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8350673 ↗
• MalfunctionFeb 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A (B)(6) RESULT FOR A (B)(6) SURVEY SAMPLE (SURVEY (B)(6), SAMPLE (B)(6)) IN ASSOCIATION WITH THE VIDAS® CMV (CYTOMEGALOVIRUS) IGG ASSAY THE CUSTOMER STATED THEY REPORTED THAT (B)(6) IGG ANTIBODIES WERE (B)(6). THEIR (B)(6) RESULT WAS (B)(6). THE EXPECTED RESULT WAS (B(6) IGG ANTIBODIES (B)(6). BIOMÉRIEUX REQUESTED THE (B)(6) SURVEY REPORT AND INSTRUCTIONS, AND THE CUSTOMER'S TEST REPORTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8322648 ↗
• MalfunctionFeb 8, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES REPORTED A (B)(6) RESULT FOR A (B)(6) SURVEY SAMPLE (SURVEY (B)(6), SAMPLE (B)(6)) IN ASSOCIATION WITH THE VIDAS® CMV (CYTOMEGALOVIRUS) IGG ASSAY THE CUSTOMER STATED THEY REPORTED THAT CMV IGG ANTIBODIES WERE (B)(6). THEIR (B)(6) RESULT WAS 7UA/ML. THE EXPECTED RESULT WAS CMV IGG ANTIBODIES NOT (B)(6). BIOMÉRIEUX REQUESTED THE (B)(6) SURVEY REPORT AND INSTRUCTIONS, AND THE CUSTOMER'S TEST REPORTS. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Patient Involvement

  MAUDE report 8322645 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K920661. One submission often covers many models, so check the product and lot details in each record.

• Z-1047-04 · Jun 9, 2004 · Terminated
  VIDAS CMV IgG Assay