E.faecalis/OE PNA FISH Intended Use: E. faecalis/OE PNA FISH" (Cat. No. KT003) is a multicolor, qualitative nucleic acid
FDA device recall Z-2315-2010 · posted 2010-08-31 · Terminated
Recall details
- Recalling firm
- AdvanDx, Inc.
- Reason for recall
- Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal.
- Action taken
- The firm, AdvanDx, sent a letter dated June 8, 2010, and email notification on June 11, 2010, to all customers. The letter described the product, problem and action to be taken by customers. AdvanDx notified the customers that there was a change to the package insert under "limitations" to include the statement "some strains of Streptococcus anginosus produce a false green positive fluorescence due to sequence similarities and enclosed a package insert for all E. facealis/OE PNA FISH (KT003) kits. The customers were instructed to replace the Package Insert (revision B) included with any kits in their inventory with the enclosed Package Insert (revision C). Note: All shipments of E. faecalis/OE PNA FISH, as of June 14, 2010, will contain this new package insert. If you have any questions or requests for further information, please contact AdvanDx Technical Support at US (Toll Free): 1-800-376-0009 or email techsupport@advandx.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OAH
- Quantity affected
- 541 units
- Distribution
- Worldwide distribution: USA and countries including Danmark, Finland and Sverige (European).
- Date initiated
- 2010-06-08
- Date posted
- 2010-08-31
- 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 |
|---|---|---|
| AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT (K083074) | Advandx, Inc. | 2009-07-24 |