Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test Recalled by Luminex Corporation Due to It was determined that the consumable issue may...
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 Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Quantity: 89 units
Why Was This Recalled?
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
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