AdvanDx EK/P. aeruginosa PNA FISH- Culture Identification Kit for identification of E. coli and/or K. pneumoniae and P.
FDA device recall Z-0491-2011 · posted 2010-12-01 · 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 sent an e-mail notification along with a PDF file to all customers on October 8, 2010, followed by written notification dated October 6, 2010. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to replace the package insert(s) included with any kits in their inventory with the enclosed package insert(s). Customers were also instructed to fill out the enclosed Acknowledgement of Receipt Form and return it to AdvanDx to confirm that they received the new package insert. For questions regarding this recall contact AdvanDx Technical Support at 1-888-376-0009.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JSS
- Quantity affected
- 27 kits
- Distribution
- Worldwide Distribution - USA including IL, MI, NY, and PA and the country of Denmark
- Date initiated
- 2010-10-08
- Date posted
- 2010-12-01
- 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 |
|---|---|---|
| EK/P. AERUGINOSA PNA FISH (K092393) | Advandx, Inc. | 2009-09-01 |