Future Diagnostics IOPTH Test System-Import Issue
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Good morning!
We recently received correspondence that the US FDA is not allowing devices and reagents to be imported into the US. I have contacted the company for further clarification to which the answer is unknown.
Does anyone have any other information? This is going to put us in a bit of predicament. Any alternatives folks are using besides the main lab? Or if using on main lab equipment what is your TATs?
Thanks so much, another day in POCT Paradise! Any info would be greatly appreciated.
Cat
We recently received correspondence that the US FDA is not allowing devices and reagents to be imported into the US. I have contacted the company for further clarification to which the answer is unknown.
Does anyone have any other information? This is going to put us in a bit of predicament. Any alternatives folks are using besides the main lab? Or if using on main lab equipment what is your TATs?
Thanks so much, another day in POCT Paradise! Any info would be greatly appreciated.
Cat
6 Replies
Hi. We moved away from Future Diagnostics when we had issues receiving supplies on time, among other issues. We moved to the Roche Cobas e411 this year. It is located in a room next to the O.R. and we have trained lab techs and CLAs to operate it, whenever a surgery is scheduled. The O.R nurse hands us the specimen, we centrifuge it, scan it into our LIS as received, place it on the analyzer (10 mins to result). Our TAT has been steady at 15 mins for the past 8 months. The OR surgeons love it, obviously because of the TAT. For now, ioPTH is the only analyte we use the analyzer for.
Thank you, Shaneece, will definitely take a look at this device.
You're welcome. It's typically used in a main lab setting because of its size, but because it's in the O.R, it was assigned to POC.
Can you please elaborate on if this is specific to that manufacturer? "The FDA is not allowing devices and reagents" for just Future Diagnostics IOPTH or for any device and reagents?
The letter was sent from Future Diagnostics and related to their products/test system.
Would you be able to share the letter?
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