Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AdvanDx E. coli/P. aeruginosa PNA FISH Recalled by Advandx Inc Due to Potential E. coli Contamination
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.
If you believe you have experienced symptoms related to this recall, contact your healthcare provider immediately.
Affected Products
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
Quantity: 33 units
Why Was This Recalled?
Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Advandx Inc
Advandx Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report