Verigene Gram Negative Blood Culture Test Recalled for Risk of False-Negative Results
Luminex Corporation is recalling 165 units of the Verigene BC-GNv2 diagnostic test worldwide due to the potential for false-negative results in blood culture testing.
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 with potential for false-negative results in diagnostic testing. The hazard is theoretical with no reported illnesses or injuries, fitting the 'High' severity category for risk-of-harm products where injury has not been reported.
Plain-English summary
Luminex Corporation is recalling 165 units of the Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2), Model Number 20-006-026, distributed worldwide. The recalled units are identified by lot codes 050620026A and 072120026B.
The product is being recalled due to the potential for false-negative results when testing blood culture samples for gram-negative bacteria. False-negative results could delay proper diagnosis and treatment of patients with bloodstream infections.
The recalled devices were distributed worldwide, including throughout the United States and to Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and the United Kingdom.
Healthcare facilities and laboratories that have received units with the identified lot codes should stop using the affected products and contact Luminex Corporation for further instructions.
The recalled product
- Product
- Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
- Manufacturer
- Luminex Corporation
- Hazard
- false-negative
- diagnostic-error
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 (1)
- 050620026A and 072120026B
Distribution
Distributed nationwide across the United States.
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