Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Verigene Processor SP Recalled by Luminex Corporation Due to Luminex has determined that three (3) separate test...
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, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
Quantity: 2838 units
Why Was This Recalled?
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENESP devices.
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