FDA Medical Device Recalls (openFDA)
AdvanDx, Inc.: AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007
- Recall number
- Z-0490-2011
- Recalling firm
- AdvanDx, Inc.
- Product
- AdvanDx E. coli/P. aeruginosa PNA FISH Culture Identification Kit for the diagnosis of E. coli and/or P. aeruginosa bacteremia Catalog Number: KT007
- Status
- Terminated
- Initiated
- 2010-10-06
- Posted
- 2010-11-29
- Terminated
- 2011-06-06
- Reason
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 260 units
- Distribution
- Worldwide Distribuition: Throughtout the US, and to the countries of Denmark, Italy, Sweden, and UK.
- Lot, serial or model codes
- Lot Codes Exp date 04310A-U8 2012-08; 03610A-U8 2012-08 ; 02110A-EU 2011-05 ; 02010A-US 2011-05 ; 00410A-US 2011-05 ; 00110A-US 2010-11 ; 07509A-EU 2010-11 ; 07009A-US 2010-11 ; 06409A-US 2010-11 ; 02909A-EU 2010-02 ; 02309A-US 2010-02;
- 510(k) numbers
- ["K092236"]
- PMA numbers
- not on file
- Product code
- JSS
- Firm FEI
- 3004080598
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28