If you have not been able to acquire the new ortho workstation and still using the old workstation that is no longer registered or listed as a cleared medical device with the FDA what action are you taking if any?

20 hours ago, Kim D said:

If you have not been able to acquire the new ortho workstation and still using the old workstation that is no longer registered or listed as a cleared medical device with the FDA what action are you taking if any?

Are you talking about this old workstation? 

 

 

Yes that is the one

Luckily we have already been using the new workstations when I came across this.  I had kept the incubator portion only of the older model like yours for back-up, and went back to using our smaller footprint, yet old, tube incubator block (can't imagine that relic is cleared either!). Once I saw that the old station was no longer FDA cleared, etc., I ordered a new tube incubator block.  I am very curious to see if the old incubator can still be used (would love to still keep as back-up) since we always check and document the temperature. 

Following - I am so glad you asked this question as I have asked the same thing to both Ortho and AABB with no direct response.

My question was, is there a requirement for an incubator and centrifuge to be an FDA cleared medical device?  We use them throughout the lab and blood bank for specimen centrifugation and for serologic tube testing, and those are not FDA cleared devices.  As long as your equipment is maintained and is meeting the requirements of the circular/instructions for use, aren't you compliant?

 

My guess would be that Ortho asked the FDA to delist - to sell more units.  I'm now using a tube incubator that is older than me (well almost) until the new one arrives.