AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bact
FDA device recall Z-0490-2011 · posted 2010-11-29 · Terminated
Recall details
- Recalling firm
- AdvanDx, Inc.
- Reason for recall
- Strains of Acinetobacter radioresistens cross-react with both E. coli/P. aeruginosa PNA FISH and EK/P. aeruginosa PNA FISH to produce a false positive red signal.
- Action taken
- AdvanDx issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert. Customers can contact AdvanDx technical support about this action at 1-866-376-0009.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JSS
- Quantity affected
- 260 units
- Distribution
- Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.
- Date initiated
- 2010-10-06
- Date posted
- 2010-11-29
- Date terminated
- 2011-06-06
- Location
- Woburn, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| E.COLI/P. AERUGINOSA PNA FISH (K092236) | Advandx, Inc. | 2009-12-16 |