CHEM8 and CG4 Blue cartridge

We pulled ours the day the notification came out.  Located in Kentucky.

  Is anyone else having issues getting CG8+ cartridges?  We use them in our OR for blood gases and since they have been allocating them we have had a lot of issues getting what we need. 

We pulled ours the next day and started ordering the EG&, we are in Central Florida. We have since ordered the Rapid Point 500 which is getting delivered today.

We have to email our sales rep every time we put in an order and somehow she's been able to get them released.  It adds a couple days to our order to shipment, but not too bad.  We're ordering earlier too, just in case they can't release the order.

Hello Reine,

Can you elaborate on your CG8+ cartridge orders?  I'm wondering how many cartridges your site orders and receives. 

We have multiple orders placed and have not received CG8+ since 01/28. 

Mary

We pulled the involved cartridges by week's end after consulting with our risk management team. CG4s we blocked the blood gas and limited the lactate use to 2 locations where there was critical need and the education requirement for those locations met high complexity standards. We will be moving to Nova lactates hopefully in the near future.

As for CG8 cartridges, we have been told to notified our Abbott contact twice a week to give our current cartridge count/numbers used and the number of CVOR/ECMO cases. I feel a bit like Oliver Twist..."please sir, I want some more".

We pulled the Chem8 and CG4 cartridges as soon as we heard the news. We have switched to a variety of interim cartridges: CG8, creat, 6+, G3+ (until we pulled those), EG7, EC8. We will use these only until we get alternatives in place. We'll be using a combination of devices eventually: ChemSTAT, Epoc, Nova Prime Plus, and GEM500. It makes me tired just to think of it. Although the Chem8 has been approved for use as moderate complexity (though I haven't seen the H/H approval yet), we will only be using i-STAT for Troponin, BNP, and ACT (at various sites). My trust in i-STAT (built over more than 20 years) is no longer. I am in New Mexico.

Yes, we're having a lot of issues. We email the rep and she tries to get the order prioritized and pushed. We're noticing the same thing with 6+.

What Debbie and I have heard is what Kathleen stated.  The Chem8 was approved, however there was no word on the H&H (Hct).  As of early this week, it was just the chemistries which had been approved .  Late this afternoon, our Abbott rep was in contact with one of our management team about the FDA approval.  Although, the question about the Hct was not brought up.  So … is this FDA approval for the FULL Chem8+ or is it the 8 minus the Hct?

Also remember that it will be moderate complexity and can't be used for capillary draws.

Does any one had the K510 FDA clrearance teport for Chem8? All I found on google search was for TCO2 and not Other analytes

Sent via Groupsite Mobile.

Is anyone bringing the now cleared Chem8 back into inventory? Are you running any sort of verification on it or no since the cartridge has not changed from previous?

It's too little too late! The lactate was the biggest loss, and that's not back. For our NICU, not having capillary samples is a no go. Also, my trust in Abbott is pretty low--will there be allocation issues with it?

We will not be bringing them back.  The new requirements to keep mod-complexity is to run it from a Li Hep and no capillary.  My users were routinely performing tests directly from the syringe and using capillary tubes.  We are in our 'window" for an inspection, it would be a simple question: "How are you running your Chem8s?   

Are you able to get the cartridges you need? We had heard that they were not sending out the white CG4+