Verigene CDF Nucleic Acid Test recalled for potential false negative results
Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test due to potential false negative results caused by the swab's hydrophobic characteristics, which could result in missed positive diagnoses.
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 medical device recall with potential for false negative diagnostic results that could delay patient diagnosis. However, the source reports no illnesses, injuries, or deaths to date; the hazard is theoretical rather than manifested.
Plain-English summary
Luminex Corporation is recalling the Verigene CDF Nucleic Acid Test (Part No. 30-002-22), a diagnostic test kit for nucleic acid detection. The recall affects 296 units distributed worldwide, including throughout the United States and internationally to Kuwait, Austria, France, Greece, and Turkey.
The test kits have a potential for false negative results due to hydrophobic characteristics of the swab used in the test. This means the test could fail to detect the presence of a pathogen or condition when it is actually present, potentially delaying diagnosis or treatment.
The recall includes units with Luminex Lot Numbers 042021022D, 071321022F, 100421022A, and 110221022E, with their corresponding FLOQ Swab lot numbers as specified in the official recall notice.
The recalled product
- Product
- Verigene CDF Nucleic Acid Test, Part No. 30-002-22
- Manufacturer
- Luminex Corporation
- Hazard
- false-negative-results
- diagnostic-inaccuracy
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 (9)
- UDI 00840487101735 Luminex Lot Number 042021022D
- FLOQ Swab Lot Numbers: 2100856
- 2032870
- Luminex Lot Number 071321022F
- 2107946
- Luminex Lot Number 100421022A
- FLOQ Swab Lot Numbers: 2110850
- Luminex Lot Number 110221022E
- FLOQ Swab Lot Numbers: 2107946.
Distribution
Distributed nationwide across the United States.
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