AdvanDx E. coli/P. aeruginosa PNA FISH recall: E. coli
AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number…
Why was AdvanDx E. coli/P. aeruginosa PNA FISH 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013
- Product
- AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number…
- Recalling firm
- Advandx Inc
- Quantity
- 33 units
- Distribution
- Worldwide distribution: USA (nationwide) including: CA, FL, IL, MI, and NJ; and country of: Great Britain.
- Recall date
- October 31, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)