Luminex Corporation recalls VERIGENE Processor SP devices with specific serial numbers due to potential false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella. Affected units may not detect these pathogens correctly when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Luminex Corporation is recalling VERIGENE Processor SP devices with specific serial numbers because they can produce false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit. This means the device might fail to detect these harmful bacteria, potentially leading to missed infections.
The VERIGENE Processor SP device can produce false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit. This means the device might fail to detect these harmful bacteria, potentially leading to missed infections and incorrect health assessments.
Users of the VERIGENE Processor SP device with specific serial numbers listed in the recall are affected. Laboratory personnel and healthcare providers who use this device for pathogen testing are most at risk of missing infections due to false-negative results.
Check the serial number on your VERIGENE Processor SP device. Affected units have specific serial numbers listed in the recall, including a range of numbers starting with 13003009 through 19095014 and other serial numbers provided in the recall notice.
Look for the serial number on your VERIGENE Processor SP device to determine if it is affected by this recall.
Luminex Corporation is recalling VERIGENE Processor SP devices with specific serial numbers due to potential false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Check the serial number on your VERIGENE Processor SP device. Affected units have specific serial numbers listed in the recall, including a range of numbers starting with 13003009 through 19095014 and other serial numbers provided in the recall notice.
The recall does not specify a remedy, so affected users should contact Luminex Corporation directly to determine next steps.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-1488-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-1488-2021 from Luminex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
