VIDAS® Mumps IgG 30218Recalls & reported problems
Biomerieux SA · VIDAS Mumps IgG (MPG) is qualitative test for use on s VIDAS family instruments for the detection of IgG antibodies to mumps virus · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026064525), received between Feb 21, 2018 and Feb 21, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- 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-0429-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
A CUSTOMER FROM THE UNITED STATES REPORTED A FALSE POSITIVE RESULT FOR A CAP SURVEY SAMPLE IN ASSOCIATION WITH VIDAS® MUMPS IGG 60TESTS. ON (B)(6) 2017, THE CUSTOMER TESTED THE SURVEY SAMPLE WITH VIDAS MUMPS IGG AND OBTAINED A POSITIVE RESULT WHEN THE EXPECTED RESULT WAS NEGATIVE. THE SAMPLE WAS RETESTED ON (B)(6) 2018 AND WAS ALSO POSITIVE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.
Patient problems: No Patient Involvement
MAUDE report 7286082 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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