AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGN
FDA device recall Z-0619-2014 · posted 2014-01-02 · Terminated
Recall details
- Recalling firm
- AdvanDx, Inc.
- Reason for recall
- Kits incompatible with certain fluorescence microscope light sources
- Action taken
- AdvanDx issued an email notification along with a PDF file of the new package insert to each customer followed by written notification dated December 6, 2013 and a paper copy of the new package insert via Fed Ex courier. All customers received an acknowledgement form to fill out and return to AdvanDx so that the effectiveness of the replacement can be evaluated. All existing inventory of Gram-Negative QuickFISH BC will be repackaged with the new package inert Customers with questions were instructed to contact AdvanDx Technical Support at 1-866-376-0009 or techwupport@advandx.com. For questions regarding this recall call 781-376-0009.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JSS
- Quantity affected
- 49 kits US; 17 kits OUS
- Distribution
- Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
- Date initiated
- 2013-12-11
- Date posted
- 2014-01-02
- Date terminated
- 2014-01-13
- 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 |
|---|---|---|
| GRAM-NEGATIVE QUICKFISH BC (K123418) | Advandx, Inc. | 2013-07-21 |