Luminex VERIGENE Processor SP Recalled for Potential False-Negative Pathogen Results
Luminex is recalling VERIGENE Processor SP units because they may produce false-negative results for specific enteric pathogens when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
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: The recall involves high-risk pathogens (Salmonella, Shigella, Vibrio) and a risk of harm (false-negative diagnostic results) where specific injury or illness reports are not stated in the source text, fitting the criteria for a High severity score.
Plain-English summary
Luminex Corporation is recalling 1,210 units of the VERIGENE Processor SP, a medical device intended for processing and identifying nucleic acids using gold nanoparticle probe technology. The recall is due to a potential for false-negative results for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when the device is used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
The affected devices were distributed worldwide, including nationwide in the United States and in Austria, France, Greece, Japan, the Netherlands, and Turkey. The recall includes both new and refurbished units of Model Number 10-0000-07 and 10-0000-07R.
Healthcare facilities and laboratories should stop using the affected devices and contact Luminex Corporation for further instructions on the recall process.
The recalled product
- Product
- VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
- Manufacturer
- Luminex Corporation
- Affected units
- 1,210
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)
- VERIGENE Processor SP: Model Number 10-0000-07
- UDI 00840487101483
- Serial Numbers 19072007
- 18255013
- 18255002
- 18159005
- 18159001
- 17215007
- 21060901
- 21055901
- 20310901
- 18023004
- 18023003
- 18023002
- 18023001
- 19072015
- 19072014
- 18318010
- 20261007
- 20261004
Distribution
Distributed nationwide across the United States.
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