Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Recalled by AdvanDx, Inc. Due to Kits incompatible with certain fluorescence microscope light sources
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 AdvanDx, Inc. directly.
Affected Products
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
Quantity: 49 kits US; 17 kits OUS
Why Was This Recalled?
Kits incompatible with certain fluorescence microscope light sources
Where Was This Sold?
This product was distributed to 9 states: CA, IL, IN, MI, MO, NJ, NY, OH, WI
About AdvanDx, Inc.
AdvanDx, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report