Device product
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.
Z-0116-2013
Product summary
- Firm
- Advandx Inc
- Event
- Event 63199
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 units
- Official record key
device-enforcement:Z-0116-2013
Official wording
Reason: 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
Code information: Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013
Distribution pattern: Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
Derived failure modes
-
Unknown
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