Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Verigene Processor SP with assay Luminex Recalled by Luminex Corporation Due to An instrument failure mode that may result in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Luminex Corporation directly.
Affected Products
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
Quantity: Total = 3,016 systems (2240 Verigene Processor SP and 776 Verigene Processor SP Refurbished)
Why Was This Recalled?
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Luminex Corporation
Luminex Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report