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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 50
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.
Part of a larger recall action
This product is one of 16 recalled by bioMerieux, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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