AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebs
FDA device recall Z-0112-2013 · posted 2012-10-22 · Terminated
Recall details
- Recalling firm
- Advandx Inc
- Reason for recall
- GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva
- Action taken
- AdvanDx sent a "GNR Traffic Light PNA FISH (KT011) Package Insert Replacement" letter dated September 14, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. All customers received an Acknowledgement Form to complete and return to AdvanDx so that the effectiveness of the replacement can be evaluated. Contact AdvanDx Technical Support at 1-866-376-0009 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JSS
- Quantity affected
- 187 kits
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Austria, Denmark, Italy, Germany, Finland, and UK.
- Date initiated
- 2012-09-14
- Date posted
- 2012-10-22
- Date terminated
- 2013-03-05
- Location
- Woburn, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.