VIDAS® Lyme IgM II 416436Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026447151), received between Dec 1, 2017 and Jan 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 22, 2021Class IIOpen, Classified

   bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.

   Z-0436-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionJan 31, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT FOR PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® LYME IGM 60 TESTS (REF 416436, LOT NUMBER NOT SPECIFIED). THE CUSTOMER TESTED THE PATIENT SAMPLE USING VIDAS® LYME IGM 60 TESTS WHICH OBTAINED A NEGATIVE RESULT. THE CUSTOMER ALSO TESTED THE SAMPLE USING WESTERN BLOT AND SOFIA TEST METHOD, BOTH ASSAYS YIELDED A POSITIVE RESULT. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9652884 ↗
• MalfunctionDec 1, 2017False Negative Result; False Negative Result

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH THE VIDAS® LYME IGM INVOLVING A PATIENT SAMPLE. THE CUSTOMER INDICATED RUNNING THE PATIENT SAMPLE AND GETTING NEGATIVE RESULT; HOWEVER, THE SAMPLE WAS SENT TO A REFERENCE LAB WHERE THE WESTERN BLOT WAS POSITIVE FOR MULTIPLE BANDS. THE CUSTOMER REPORTED THE SPECIMEN THEY TESTED AND THE SPECIMEN THE REFERENCE LAB TESTED WERE OBTAINED FROM THE PATIENT AT THE SAME TIME BUT WERE IN DIFFERENT TUBES. SERUM WAS USED FOR BOTH TESTS. THE CUSTOMER INDICATED NEITHER SPECIMEN IS AVAILABLE FOR SUBMISSION TO BIOMÉRIEUX.. A BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7076035 ↗