I-STAT Troponins

Hi Cindy, I have not seen anything from Abbott regarding the troponin cartridges. Can you please elaborate on what the notice said? We use istat troponin cartridges only on babies and very rarely. Thanks. 

What's going on

Abbott lost FDA clearance for their troponin cartridges. We pulled ours as well- this is a major hit to our level 1 trauma ED! No idea what we will do now, long term. For now, sending all troponins to the main lab. 

They currently do not have 510k clearance because of various changes they made to the cartridge over the years but did not submit the changes to the FDA. Our rep called this morning and shared the letter from Abbott. So, if you continue to use the cartridge, it now becomes a lab developed test. 

Where is this information at

Oh no, here we go again with Abbott. Does anyone have a link to the news bulletin or article? I need something to show to our lab medical director tomorrow. This is going to be an issue. 

Tamara- I too got a letter via my Abbott rep. It isn’t on the Abbott or FDA website yet. I would recommend getting in touch your rep asap

Thank you for the link. 

Thank u so much 

The letter says it's ok to use as a non-waived POC test. FDA allowed the usage to continue. I did not understand from my conversation with my rep or the letter that the test became a lab developed test. 

Yes- okay to use it without FDA clearance or emergency use authorization.

The letter states the cartridges will remain available.  The FDA letter dated 11/8/22 warned they are not FDA cleared.  I think we'll pull them until I see clearance on the FDA site.

can you post a copy of the FDA letter?

That's what I posted- that is the letter the FDA required Abbott to send out to their customers