Verigene Gram-Positive Blood Culture Test Recalled for Potential False-Negative Results
Luminex Corporation is recalling the Verigene BC-GP blood culture test (Model 20-006-018) due to the potential for false-negative results. Approximately 36,416 units have been distributed worldwide.
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 a Class II FDA recall of a diagnostic test with potential for false-negative results—a risk-of-harm product where injury has not yet been reported. No deaths, illnesses, or injuries are documented in the recall notice.
Plain-English summary
Luminex Corporation is recalling the Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP), Model Number 20-006-018, a diagnostic test used to identify bacteria in blood cultures. Approximately 36,416 units have been distributed.
The recalled units have the potential to produce false-negative results, meaning the test may fail to detect organisms when they are actually present in a sample.
The product has been distributed worldwide, including throughout the United States and to the countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and the United Kingdom.
Healthcare providers and laboratory personnel using the Verigene BC-GP should contact Luminex Corporation for information about affected unit lot codes and further guidance. The FDA has designated this as a Class II recall.
The recalled product
- Product
- Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
- Manufacturer
- Luminex Corporation
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-negative-result
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 (20)
- 030620018A
- 031420018A
- 032020018A
- 040120018A
- 041020018B
- 041720018B
- 042420018A
- 043020018A
- 050220018A
- 050720018A
- 050920018A
- 051320018A
- 051420018A
- 051520018A
- 052020018A
- 052120018A
- 052920018A
- 060220018A
- 060920018A
- 061020018A
Distribution
Distributed nationwide across the United States.
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