VIDAS® FSH 30407-01Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

1 other recall cover devices cleared under the same FDA submission (K921746); 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.

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-0434-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K921746. One submission often covers many models, so check the product and lot details in each record.

• Z-2331-2018 · Apr 9, 2018 · Terminated
  VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an