Posted by Sten Westgard, MS
Recently a colleague of mine pointed out a website that tracks and sends out regular alerts concerning IVD recalls and issues. While the FDA has some of the same information, there isn't (to my knowledge) an alert system you can subscribe to.
So, can you guess how many IVD recalls there were in 2013? Can you guess which manufacturer had the highest number of recalls or issues? More after the jump...
First, here are the full lists of entries on the recalls and corrective actions list:
http://www.swissmedic.ch/rueckrufe_medizinprodukte/index.html?lang=en
http://www.swissmedic.ch/rueckrufe_medizinprodukte/archiv/index.html?lang=en&RlArchiv=2013-07
If you cull through the list and focus only on the IVD manufacturers, particularly the major companies, this is what you'll see for 2013:
Some caveats: first, this is a list maintained by a Swiss agency, so it is not necessarily reporting everything that might be happening in the US. Second, each entry on this list may in fact cover multiple problems on multiple instruments. Third, some of these entries are updates on previous entries.
In other words, this isn't an exact count of all the problems that different diagnostic manufacturers are experiencing. But it does give you an idea of who's having a good year and a bad year, and which customers are probably happier than others.
The nice thing about this list is that it will periodically email you the latest recalls, and each recall includes the links to the official releases and descriptions of problems.
Interesting & useful, but I wonder if the reader should also be informed that Siemens is much more prevalent in Europe than Beckmann. Very informative nonetheless!
Posted by: Chad | December 19, 2013 at 12:03 AM