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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Advandx Inc
- Reason for Recall:
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0116-2013
Related Recalls
Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC
Kits incompatible with certain fluorescence microscope light sources
GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva