Luminex Verigene C. difficile Test Kit Recalled for False-Negative Results
Luminex Corporation is recalling 1,261 Verigene Clostridium difficile test kits due to potential for false-negative results. The kits may fail to detect C. difficile infections, potentially delaying diagnosis.
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 medical device with potential for patient harm—false-negative test results could delay C. difficile diagnosis. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without documented actual harm score a maximum of 3.
Plain-English summary
Luminex Corporation has recalled 1,261 units of the Verigene Clostridium difficile Nucleic Acid Test Kit (CDF), Model Number 20-006-022, bearing lot codes 041520022A, 061920022A, and 081120022A.
The kits carry a potential for false-negative results. A false-negative result means the test may fail to detect C. difficile bacteria in a patient sample despite active infection. This could lead to missed diagnoses and delayed treatment initiation.
The affected kits have been distributed worldwide, including throughout the United States and in Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and the United Kingdom.
Healthcare facilities and laboratories with affected lot codes should immediately stop using these kits and contact Luminex Corporation for guidance on replacement or alternative testing methods.
The recalled product
- Product
- Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
- Manufacturer
- Luminex Corporation
- Hazard
- test-inaccuracy
- diagnostic-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 (3)
- 041520022A
- 061920022A
- and 081120022A
Distribution
Distributed nationwide across the United States.
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