VERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
Luminex is recalling the VERIGENE C. difficile diagnostic test due to the possibility of false-negative results in rare instances caused by hydrophobic characteristics in specific FLOQSwab lots.
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: This is an FDA Class II diagnostic device for a high-risk pathogen (C. difficile) that could produce false-negative results. No illnesses or injuries have been reported related to this defect, placing it in the risk-of-harm category without documented injury.
Plain-English summary
Luminex Corporation is recalling the VERIGENE Clostridium difficile Nucleic Acid Test (REF 30-002-022), which was distributed worldwide and throughout the United States. Affected lot numbers include 071222022D and 100622022D. The recall affects 114 units.
The test could provide false-negative results in rare instances due to hydrophobic characteristics in specific FLOQSwab lots. A false-negative result means the test fails to detect the presence of C. difficile in a patient sample.
The recalled product
- Product
- VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Manufacturer
- Luminex Corporation
- Affected units
- 114
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 (3)
- UDI/DI
- Lot Numbers: 071222022D
- 100622022D
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Luminex Corporation 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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