The Recall Desk
HighFDA (Devices)·Z-0426-2022·Announced 2022-01-05

VIDAS Clostridium Difficile GDH test substrate error causes test failure

bioMerieux recalls VIDAS Clostridium Difficile GDH diagnostic test kits due to a substrate error that prevents test execution. Affected users must retest samples, potentially delaying results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II diagnostic device with a substrate error that prevents test execution. This is a risk-of-harm product where the defect may delay diagnosis of a potentially serious condition, though no illnesses or injuries have been reported.

Plain-English summary

bioMerieux is recalling VIDAS Clostridium Difficile GDH test kits (REF 30125-01, Lot 1008686690) due to a substrate error that prevents test execution. The affected kits have nationwide US distribution.

When the substrate error occurs, the test cannot be run. Users encountering this error must perform another test on the sample, which delays diagnostic results.

Laboratories and healthcare facilities using this product should contact bioMerieux for guidance on identifying and handling affected units.

The recalled product

Product
VIDAS Clostridium Difficile GDH, REF 30125-01
Manufacturer
bioMerieux, Inc.
Category
Medical Device — Diagnostic test
Hazard
  • substrate-defect
  • test-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI 03573026444204
  • Lot #s: 1008686690

Distribution

Distributed nationwide across the United States.

Related recalls

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