iSTAT ACT issues
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Starting a new thread to bring it back to the top of conversation.
We are still experiencing random issues with iSTAT ACT's not being at therapeutic levels after dosing of heparin, causing lots of issues with our physicians. iSTAT cannot give any information other that they will put out a letter of their findings "sometime"?? We are very frustrated with the situation, ACT cartridges are now on back order, control is hard to get--just wondering if the letter will say they are no longer going to produce ACT cartridges and leave us all in a panic or the "we could not find anything wrong after investigation" letter.
We have been a long-time customer of iSTAT but have mostly just been disappointed with them since Jan 2020 when they had their massive recall with FDA and then suddenly a few weeks later when Covid hit, they were fine. I feel like we are getting some sort of communication from them every 4-6 months about a recall of cartridges, discontinuing a cartridge, changed the room temp on EG7 for a while, changing acceptable sample types, the list goes on.
Has anyone found a solution or what the problem is/was? Are you still having issues? What are your solutions? Bringing in a new instrument is no quick and easy task as you all know. Just feeling frustrated :(
We are still experiencing random issues with iSTAT ACT's not being at therapeutic levels after dosing of heparin, causing lots of issues with our physicians. iSTAT cannot give any information other that they will put out a letter of their findings "sometime"?? We are very frustrated with the situation, ACT cartridges are now on back order, control is hard to get--just wondering if the letter will say they are no longer going to produce ACT cartridges and leave us all in a panic or the "we could not find anything wrong after investigation" letter.
We have been a long-time customer of iSTAT but have mostly just been disappointed with them since Jan 2020 when they had their massive recall with FDA and then suddenly a few weeks later when Covid hit, they were fine. I feel like we are getting some sort of communication from them every 4-6 months about a recall of cartridges, discontinuing a cartridge, changed the room temp on EG7 for a while, changing acceptable sample types, the list goes on.
Has anyone found a solution or what the problem is/was? Are you still having issues? What are your solutions? Bringing in a new instrument is no quick and easy task as you all know. Just feeling frustrated :(
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@Kristine Zinn above - I am curious about CAP's response about AMR for ACT. I perform the AMR for new devices validation, but never afterwards. In regulation POC.08450 it says: The AMR does not apply to clot-based coagulation tests.
Can anyone share information that they have on heparin being the culprit? I can't find any recalls; our pharmacy group is aware but say they have tested the concentrations of our heparin and they are good. I have noticed the patients that we have gotten documentation on have all used Meitheal brand. Curious to any documentation or if it's just complaints filed without any answers.