VIDAS® RUB IgG 30226Recalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 still open.

3 other recalls cover devices cleared under the same FDA submission (K141133); 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 16, 2026.

Recalls naming this device

1. Nov 9, 2022Class IIOpen, Classified

   As the temperature and time out of range was exceeded, product performances cannot be guaranteed

   Z-0797-2023 · Root cause: Storage · Recall details · FDA record ↗

2. 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-0432-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141133. One submission often covers many models, so check the product and lot details in each record.

• Z-0864-2023 · Nov 9, 2022 · Open, Classified
  VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
• Z-0427-2022 · Sep 22, 2021 · Open, Classified
  VIDAS DEX@, Dimer Exclusion II, REF 30455-01
• Z-0928-2020 · Oct 22, 2019 · Terminated
  BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation